Audit & Certification
At Azierta, we offer a worldwide audit service. With our teams of local experts, we enable companies to optimise their resources, improving the time and scope of each audit. Our service ensures the comfort and ease of the process managed by a single representative: Azierta.
- Supplier Audit Reports -
Discover our extensive database with available reports. Our audit reports have been performed by our highly experienced local auditors with suppliers worldwide. Save time and optimise resources.
| MATERIAL | SUPPLIER | COUNTRY | STATUS | YEAR | MONTH | ADDRESS |
|---|---|---|---|---|---|---|
| FUROSEMIDE EP | SRI KRISHNA PHARMACEUTICALS LTD. | India | PERFORMED | 2022 | January | |
| PV | Al-Maseela Pharmaceutical | Kuwait | PERFORMED | 2022 | January | |
| PERMETHRIN | Azico Biophore | India | PERFORMED | 2022 | February | |
| PV | Farmaceutica Lanquetin | Guatemala | PERFORMED | 2022 | February | |
| PV | Taiba Pharma LLC | Oman | PERFORMED | 2022 | March | |
| Midazolam | Sun Pharma | India | PERFORMED | 2022 | March | |
| KETOPROFEN | Hubei Xunda Pharmaceutical Co Ltd. | China | PERFORMED | 2022 | March | |
| BORTEZOMIB (K) | Hetero Labs Limited (Unit - I) | India | PERFORMED | 2022 | March | |
| VF | Megalabs | Ecuador | PERFORMED | 2022 | March | |
| THIOCOLCHICOSIDE, ENOXOLONE | Alchem International Private Limited | India | PERFORMED | 2022 | April | |
| PET BOTTLES | INDEN-PHARMA PACKAGING | Spain | PERFORMED | 2022 | April | |
| Ivabradine, pitavastatin calcium | Cadila Healthcare Ltd. (formely known as Banyan Chemicals Ltd) | India | PERFORMED | 2022 | April | |
| Tadalafil | Alembic Pharmaceutical Ltd. | India | PERFORMED | 2022 | April | |
| Lidocaine Hydrochloride | Gufic Biosciences Limited | India | PERFORMED | 2022 | April | |
| ALUMINIUM ALVEOLAR, ALUMINIUM ANONYMOUS, ALUM+POLYAMIDE+PVC (Alu/Alu) | Aluberg S.PS.A | Italy | PERFORMED | 2022 | May | |
| Sertraline | Wanbury Limited (Doc Division) | India | PERFORMED | 2022 | May | |
| Valves | PRESSPART MANUFACTURING | Spain | PERFORMED | 2022 | May | |
| Ondansetron | Sun Pharma | India | PERFORMED | 2022 | May | |
| BECLOMETHASONE DIPROPIONATE, Betamethasone Valerate, Dexamethasone Sodium Phosphate, Prednisolone sodium Phosphate | Curia Spain S.A.U. | Spain | PERFORMED | 2022 | May | |
| Dexmedetomidine | Grindex | Latvia | PERFORMED | 2022 | May | |
| Crystal sugar | Cristal Union | France | PERFORMED | 2022 | June | |
| IMUNOCARE | GLENMARK IMUNOCARE | India | PERFORMED | 2022 | June | |
| Sertraline hydrochloride normal and alternative process | Hetero Drugs Limited (unit I) | India | PERFORMED | 2022 | June | |
| Mupirocin | Hangzhou Zhongmei Huadong Pharmaceutical Jiangdong Co. LTD | China | PERFORMED | 2022 | June | |
| Carbocisteine, Carbocysteine Lysine salt (Salt: under evaluation) | PHARMAZELL | India | PERFORMED | 2022 | June | |
| ALOCARE and CELLMUNE | INTAS | India | PERFORMED | 2022 | June | |
| Slicarbazapine acetate | Lupin Limited | India | PERFORMED | 2022 | June | |
| DICLOFENAC SODIUM | Henan Dongtai Pharm Co Ltd | China | PERFORMED | 2022 | June | |
| Ascorbic Acid | CSPC Weisheng Pharmaceutical (Shijiazhuang) Co., Ltd. | China | PERFORMED | 2022 | June | |
| DROTAVERINE HYDROCHLORIDE | ZHEJIANG APELOA KANGYU | China | PERFORMED | 2022 | June | |
| ENALAPRIL MALEATE | Zhejiang Changming Pharm Co. Ltd.. | China | PERFORMED | 2022 | June | |
| Ciprofloxacin | Aarti Drugs Ltd. (plot E21/22) | India | PERFORMED | 2022 | July | |
| LANREOTIDE ACETATE | Sinopep-Allsino Biopharmaceutical Co., Ltd | China | PERFORMED | 2022 | July | |
| Losartan | VASUDHA Pharma Chem Limited, Unit-II | India | PERFORMED | 2022 | July | |
| Escitalopram | Micro Labs Limited | India | PERFORMED | 2022 | July | |
| PARACETAMOL MICRONIZED POWDER, PARACETAMOL DC 90-5 90% | ANQIU LUAN PHARMACEUTICAL CO. LTD. | China | PERFORMED | 2022 | July | |
| Galeniq 900 (Isomalt) | BENEO Gmbh | Germany | PERFORMED | 2022 | July | |
| Citalopram hydrobromide, olanzapine and eslicarbazepine | Jubilant Generics Limited (antes llamado Jubilant Life Sciences, Jubilant Organosys Limited (antes llamado MaxPharma)) | India | PERFORMED | 2022 | July | |
| KETOPROFEN | ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD. | China | PERFORMED | 2022 | August | |
| PV | Experior | Valencia | PERFORMED | 2021 | 3/4-jun-21 | |
| DEFLAZACORT | Crystal Pharma | Valladolid | PERFORMED | 2021 | 17/06/2021 | |
| Control laboratory | Kymos, S.L. | Barcelona | PERFORMED | 2021 | 20/07/2021 | |
| Rosuvastatin calcium | XUANCHENG MENOVO PHARMACEUTICAL CO. LTD | China | PERFORMED | 2021 | 06/08/2021 | |
| Carbocysteine Lysine salt | Zhejiang Sanmen Hengkang | China | PERFORMED | 2021 | 03/11/2021 | |
| Azithromycin and Clarithromycin | ERCROS INDUSTRIAL S.A. | Madrid | PERFORMED | 2021 | 09/11/2021 | |
| Fusidic acid | ERCROS INDUSTRIAL S.A. | Madrid | PERFORMED | 2021 | 09/11/2021 | |
| Deflazacort | Crystal Pharma | Spain, Valladolid | PERFORMED | 2021 | 17/06/2021 | |
| Control Laboratory | Kymos, S.L. | Spain, Barcelona | PERFORMED | 2021 | 20/07/2021 | |
| Rosuvastatin calcium | XUANCHENG MENOVO PHARMACEUTICAL CO. LTD | China | PERFORMED | 2021 | 06/08/2021 | |
| Micronized Finofibrate Gemfibrozil Meloxicam | ZHEJIANG EXCEL PHARMACEUTICAL CO., LTD- | China | PERFORMED | 2020 | 6-7/01/2020 | 09 DAZHA ROAD, HUANGYAN ECONOMIC DEVELOPMENT ZONE, TAIZHOU, ZHEJIANG, CHINA |
| Methaclopramide | Ipca Laboratories | INDIA | PERFORMED | 2020 | 07/01/2020 | .0. Sejavta,Ratlam - 457002 Madhya Pradesh - India Phone : 07412-278000 |
| Levocetirizine and ramipril | Dr. Reddy's | India | PERFORMED | 2020 | 08/01/2020 | |
| Zonisamide hard capsules | Laboratorios Normon | Spain | PERFORMED | 2020 | 30/01/2020 | Ronda de Valdecarrizo, 6, Tres Cantos, Madrid 28760 |
| Amiodarone hydrochloride Carvedilol Hydrochlorothiazide Irbesartan Lamotrigine Ondansetron hydrochloride dihydrate. | CTX LIFESCIENCES PVT LTD | India | PERFORMED | 2020 | 3&4-02-2020 | BLOCK NO. 251-252, SACHIN MAGDALLA ROAD, SACHIN GIDC, SACHIN, SURAT, GUJARAT, 394230 INDIA |
| Lidocaine hydrochloride +Amylmethacresol +2,4-dichlorobenzylalcohol | LOZYS PHARMACEUTICALS S.L. | Spain | PERFORMED | 2020 | 12/02/2020 | Calle, Colegio Lekaroz, s/n, 31795 Lecároz, Navarra |
| Lidocaine hydrochloride +Amylmethacresol +Dichlorobenzylalcohol | GEISER PHARMA | Spain | PERFORMED | 2020 | 13/02/2020 | Calle Camino de Labiano, 45, 31192 Mutilva Alta, Navarra. 42.796605, -1.614390 |
| Esomeprazole magnesium trihydrate powder; olanzapine; quetiapine fumatare; rabeprazole sodium | Nifty Labs PVT. LTD | India | PERFORMED | 2020 | 18y19-feb-2020 | PLOT NOS. 50-A,B, G&H, 64-A,B, C&D, 65-A,B, C&D, 66-A&B, 67-A&B, IDA KONDAPALLY, LBRAHIMPATNAM, KRISHNA DIST, A.P., INDIA, PIN: 521 228 |
| Veegum HV Granules EP (Aluminium Magnesium Silicate) | Vanderbilt Company Inc. | USA | PERFORMED | 2020 | 20/02/2020 | Murray Division, 396 Pella Way, Murray, KY, 42071, USA) |
| LORATADINE LOSARTAN POTASSIUM. | VASUDHA PHARMA CHEM LIMITED | INDIA | PERFORMED | 2020 | 20/02/2020 | PLOT NO. 79, JAWAHARLAL NEHRU PHAM1A CITY, THANAM V11LAGC ,PARAWADA (M), V1SAKHAPATNAM-531019,ANDHRA PRADESH, INDIA. |
| Ephedrine Hydrochloride | SINTÉTICA | Switzerland | PERFORMED | 2020 | 26/02/2020 | Sintetica SA, Via Penate 5, 6850 Mendrisio, Suiza |
| Ephedrine Hydrochloride | SINTÉTICA BIOREN S.A. | Switzerland | PERFORMED | 2020 | 27/02/2020 | Rue des Iles 4B, 2108 Val-de-Travers, Suiza |
| atorvastatin calcium trihydrate, desloratadine; montelukast sodium | MOREPEN LABORATORIES LIMITED - INDIA | INDIA | PERFORMED | 2020 | 05,06-03-20 | VIII. MALKUMAJRA (MOREPEN VILLAGE). BADDI-NALAGARH ROAD, BADDI, DISTT. SOLAN, (HIMACHAL PRADESH)-173 205 INDIA |
| Logistic operator | RDA Ramoneda | Spain | PERFORMED | 2020 | 05&06/03/2020 | Avinguda Torre d'en Mateu, 151, 08210 Barberà del Vallès, Barcelona |
| GLP | NETPHARMALAB | SPAIN (MAD) | PERFORMED | 2019 | 10/01/2019 | |
| TRDI10Trimetazidine 2HCL | BACHEM | Switzerland | PERFORMED | 2019 | 05/02/2019 | ROUTE DU SIMPLON 22 CH-1895 VIONNAZ SWITZERLAND |
| RIVA10 Rivaroxaban Moehs D90<10 | AMINOCHEMICALS | MALTA | PERFORMED | 2019 | 07/02/2019 | MRA 050X, INDUSTRIAL ESTATE, Marsa MRS 3000 Malta |
| BETAMETHASONE PHOSPH.SOD. MOMETASONE FUROATE MOMETASONE FUROATE AND METHYLPREDNISOLONE ACEPONATE BUDESONIDE MICRONIZED DEXAMET.SOD.21PHOSPH.LYOPHILIZED "BUDESONIDE MICRONIZED | CRYSTAL PHARMA, S.A. (BOECILLO/VALLADOLID) | SPAIN (VLL) | PERFORMED | 2019 | 21/02/2019 | Parque Tecnológico, parcela 105 47151 BOECILLO VALLADOLID SPAIN |
| BUDESONIDE MICRONIZED | SICOR SOC. | Italy | PERFORMED | 2019 | 26/02/2019 | Tenuta S.Alessandro IT-13408 SANTHIA (VERCELLI) ITALY |
| Intermediate KSM-MTS4 for montelukast sodium (Morepen nomenclature) | MUNDANJIANG HENGYUAN | China | PERFORMED | 2019 | 28/02/2019 | No. 332, Daqing street. Aimin District China-157 000 Mudankiang City, Heilongiang Province |
| Copidogrel and Famotidine | CADILA HEALTHCARE | INDIA | PERFORMED | 2019 | 01/03/2019 | Dirección: Plot no. 26, 29 & 31 Dabhasa- Umaraya Road, Dabhasa 391 440, Tal Padra Dist. Vadodara, Gujarat, India |
| NaCl | CFL-Chemische Fabrik Lehrte GmbH | Germany | PERFORMED | 2019 | 05/03/2019 | K G - Ko?thenwaldstraße 2-6- 31275 Lehrte - Germany |
| Laboratory Analysis | DIAPHARM Analytics GmbH | Germany | PERFORMED | 2019 | 06/03/2019 | Würzburger Str. 3 26121 Oldenburg. Germany |
| Microbiology testing | Eurofins | FRANCE | PERFORMED | 2019 | 07/03/2019 | 16 Rue Clement Ader F-68127 - SAINTE CROIX EN PLAINE FRANCE |
| Cloperastine Fendizolate | PEN TSAO | China | PERFORMED | 2019 | 08/03/2019 | M/s. Pen Tsao Chemical & Pharmaceutical Industry Company Limited, nº2 Tieli Road, Wusong, Shanghai 200940, PR China CHINA |
| Sucrose Na2HPO4 Progesterone Soft Capsules Ramipril Diethylene glycol Sodium Polystyrene Sulfonate, Calcium Polystyrene Sulfonate and Cholestyramine Glucosamine Sulfate Lepor GDP Audit Anhydrous Sodium Sulfate Microbiological analysis Valsartan Diosmin micronized Interquim Donacilus and Floradela capsules PYRIDOSTIGMINE BROMIDE Progesterone | Carlo Erba | France | PERFORMED | 2019 | 13/03/2019 | Carlo Erba Reagents S.A.S. Chaussée du Vexin 27106 Val de Reuil cedex France |
| Progesterone Soft Capsules | CAPSUGEL | France | PERFORMED | 2019 | 14/03/2019 | ZI Camagnon, BP 320 56803 - PLOERMEL Cedex FRANCE |
| Ramipril | ZHEJIANG CHANMING PHARMACEUTICAL CO., LTD | China | PERFORMED | 2019 | 19/03/2019 | No. 1, Badu Road. Tiantai Industrial Park. Chiina-317 200 Tiantai, Zhejiang Province |
| Diethylene glycol | INEOS Belgium | Belgium | PERFORMED | 2019 | 20/03/2019 | Haven 1053 Nieuwe Weg 1, B-2070 Zwijndrecht, Belgium |
| Sodium Polystyrene Sulfonate, Calcium Polystyrene Sulfonate and Cholestyramine | PUROLITE | Romania | PERFORMED | 2019 | 21/03/2019 | Str. Aleea Uzinei nº 11. 505700 Victoria JUD.BRASOV ROMANIA |
| Glucosamine Sulfate Lepor | ESTEVE | SPAIN (GER) | PERFORMED | 2019 | 26/03/2019 | TP-2125 Carretera del Vendrell a St Jaume dels Domenys Km 5,4, Banyeres del Penedés, Tarragona, Spain |
| GDP Audit | EXPRESS PHARMA | Albania | PERFORMED | 2019 | 27/03/2019 | |
| Anhydrous Sodium Sulfate | Macco Organiques, S.R.O. | CZECH REP | PERFORMED | 2019 | 04/04/2019 | Zahradni 1938/46 c Czech Republic 792 01 Bruntál |
| Microbiological analysis | CIFA, Laboratorio de Microbiología de Alimentos Y Aguas | SPAIN | PERFORMED | 2019 | 05/04/2019 | C/Irunlarrea s/n 31008 Pamplona (Navarra) España |
| Valsartan | Dr. Reddy´s | INDIA | PERFORMED | 2019 | 08/04/2019 | APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India |
| Diosmin micronized Interquim | INTERQUIM S.A. | SPAIN | PERFORMED | 2019 | 09/04/2019 | Ctra. De Zeneta 143 -145, El Raiguero - La villa, 30130 Beniel (Murcia) ESPAÑA |
| Donacilus and Floradela capsules | BIOFARMA | Italy | PERFORMED | 2019 | 09/04/2019 | Vía Castelliere, 2 33036- Mereto di Tomba (UD) ITALY |
| PYRIDOSTIGMINE BROMIDE | Patheon Austria GmbH & CO (before Dpx Fine chemicals Austria DSM | Austria | PERFORMED | 2019 | 10/04/2019 | Patheon Austria GmbH & CO (before Dpx Fine chemicals Austria DSM), St. Peter StraBe , 25. 4021 Linz Austria |
| Progesterone | PHARMACIA & UPJOHN COMPANY (PFIZER) | USA | PERFORMED | 2019 | 10/04/2019 | 7000 Portage Road United States - 49001-0199 Kalamazoo, Michigan USA |
| Neomycin sulfate | PHARMACIA & UPJOHN COMPANY (PFIZER) | USA | PERFORMED | 2019 | 10/04/2019 | 7001 Portage Road United States - 49001-0199 Kalamazoo, Michigan USA |
| Prednisone, Prednisolone | Henan Lihua Pharmaceuticals co. Ltd | China | PERFORMED | 2019 | 19/04/2019 | Tongyuanxi, Dazhan, Xianju, Zhejiang Province, 317321, P.R. China |
| ORPHENADRINE CITRATE | ALBERMALE CORPORATION (DSM Pharma Chemicals North America) | USA | PERFORMED | 2019 | 23/04/2019 | 1421 Kalamazoo Street , South Haven Plant (Michigan- MI 49090 USA) |
| National transportation of medicines. | OFSA | SPAIN (GUA) | PERFORMED | 2019 | 24/04/2019 | Polígono El Henares, Av. Cristobal Colón, 245 19180 MARCHAMALO - GUADALAJARA España |
| Physical-chemical analysis laboratory. | Intertek Pharmaceutical Services Manchester | UK | PERFORMED | 2019 | 30/04/2019 | PO Box 42 Hexagon Tower Crumpsall Vale off Delauney's Road Blackley Manchester M9 8ZS |
| Glucose Monohydrate | Roquette Frères | FRANCE | documental audit | 2019 | 06-05-19 | La Haute Loge - France - 62080 Lestrem |
| LAURIMIC CREAM (Fenticonazole 2%) | FARMALABOR | Portugal | PERFORMED | 2019 | 09/05/2019 | Zona Industrial de Condeixa, Sebal Grande Condeixa-a-Nova 3150-194 PORTUGAL |
| Ezetymib API Pregabalin API Rosuvastatin calcium intermediates (19-TBPO) Rosuvastatin calcium intermediates (19-TBPO) (TBRE) | Teva API India Limited - Gajraula site | INDIA | PERFORMED | 2019 | 10/05/2019 | Plot Nos. A-2, A-2/1 & A-2/2 UPSIDC Industrial Area Bijnor Road, Distt. J.P. Nagar Gajraula-244 235 (Uttar Pradesh), India |
| Losartan potassium | Vasudha Pharma Chem Limited | INDIA | PERFORMED | 2019 | 14/05/2019 | Plot No. 79, Jawaharla Nehru Pharma City Parawada INDIA-531 019 Visakhapatnam, Andhra Pradesh |
| Zolpidem tartrate | UQUIFA MEXICO | MEJICO | PERFORMED | 2019 | 15/05/2019 | Calle 37 este, nº126.62500 CIVAC.Jiutepec Morelos México |
| MINOXIDIL | ICROM, S.p.A. (CONCOREZZO - ITALIA) | Italy | PERFORMED | 2019 | 22/05/2019 | 5043 Via delle Arti, 33 20863 CONCOREZZO ITALY |
| National transportation of medicines. | OLMED | Spain | PERFORMED | 2019 | 22/05/2019 | Valdemoro, Madrid |
| (Packaging / Food supplements) | SWISSCAPS | Germany | PERFORMED | 2019 | 22/05/2019 | GRASSINGERSTR.9, BAD AIBLING 83043 GERMANY |
| (manufacturer of Fluconazole soft capsules) | KLOCKE | Germany | PERFORMED | 2019 | 23/05/2019 | Straßburger Straße 77, D-77767 Appenweier-Urloffen GERMANY |
| Analytical Laboratory | Pharmaprogress | Italy | PERFORMED | 2019 | 29/05/2019 | Via Alessandro Volta, 12 60020 - Camerata Picena (Ancona) Italy |
| Trypticasein Soy Broth | LABORATORIOS CONDA | SPAIN | PERFORMED | 2019 | 06/06/2019 | C/ Forja, 9. Torrejón de Ardoz - 28850-Madrid |
| FLUCONAZOL | QUÍMICA SINTÉTICA | SPAIN | PERFORMED | 2019 | 12/06/2019 | Calle de Dulcinea, s/n 28805 Alcalá de Henares Madrid (SPAIN) PRODUCTO: API |
| CE marked scoops. | Stiplastics | FRANCE | PERFORMED | 2019 | 05/06/2019 | 62, chemin des Plantées 38160 Saint-Marcellin Francia |
| Plastic | Gerresheimer | SPAIN | PERFORMED | 2019 | 12/06/2019 | P.I. Valdemuel, Camino del Sabinar, s/n 50290 Epila (Zaragoza) Spain |
| MP1S10 - 0865 - 0001: sterile PE bags NP1R10-0865-0001: sterile Ny/PE bags HRSU10S0865-0001: sterile PE/Al bags. | PALL | Belgium | PERFORMED | 2019 | 18/06/2019 | Pall Life Sciences BVBA |Reugelstraat 2 | 3320 Hoegaarden, Belgium |
| FLUMAZENIL, GRANISETRON AND TRAMADOL | PERRIGO API (Israel) Boralquimica | Israel | PERFORMED | 2019 | 19 y 20-jun-19 | Ramat Hovav, Beer-Sheva, Israel |
| Levetiracetam | Aurobindo Pharma LTD. | INDIA | PERFORMED | 2019 | 19/06/2019 | Unit XI, Sy. Nos, 1/22, 2/1 to 5,6, to 18,61 to 69 Pydibhimavaram (V), Ranasthalam Mandal, Srikakulam Dist, Andra Pradesh, INDIA Phone: +918942 288292 |
| LEVOFLOXACIN | NEULAND (India) Azelis Unit I | INDIA | PERFORMED | 2019 | 24/07/2019 | Bonthapalli (V), Jinnaram (M) Medak Dist., 502313 Telangana India |
| Tobramycin PT and Conditioning | Holopack Verpackungstechnik GmbH | Germany | PERFORMED | 2019 | 04/07/2019 | Untergröningen, Germany/Bahnhof Strabe 18 74429 Sulzbach-Laufen Deutschland Germany |
| Roflumilast, Celecoxib, Solifenacin | INTERQUIM S.A. | SPAIN | PERFORMED | 2019 | 16/07/2019 | c/ Joan Buscallá 10, E-08173 San Cugat del Vallés, Barcelona |
| Plastic containers | Bormioli Saint Sulpice | FRANCE | PERFORMED | 2019 | 17/07/2019 | Z.A.E. Les Cadaux, 81370 SAINT-SULPICE, France |
| Dosing cup and safety cap | Bormioli Saint Sulpice | FRANCE | documental audit | 2019 | 17/07/2019 | Z.A.E. Les Cadaux, 81370 SAINT-SULPICE, France |
| "- Validation of microbiological methods, - Growth promotion studies in culture media - Microbiological testing of pharmaceutical products- Microbial identifications" | Biolab, S.L. | Spain | PERFORMED | 2019 | 18/07/2019 | Avenida de los Reyes nave 59, Pol. Ind. La Mina Colmenar Viejo 28770, Madrid España |
| SILO10 SILODOSINA HUAHAI. SILO20 SILODOSINA micro (D90) 10-25 huahai Levetiracetam | Zhejiang Huahai pharmaceutical Co Ltd Chuannan. | China | PERFORMED | 2019 | 23/07/2019 | nº 1 branch Duquiao- Coastal Industrial Zone, Duqiao, Linhai. Zhejiang, 317016 CHINA |
| Custodia docum. | IRON MOUNTAIN I | Spain | PERFORMED | 2019 | 26/07/2019 | C/ Bronce 37 Polígono Industrial Albolleque - 19160 Chiloeches (Guadalajara) |
| Custodia docum. | IRON MOUNTAIN II | Spain | PERFORMED | 2019 | 02/08/2019 | C/ Reyes Católicos, 6 Polígono Industrial Valgrande - 28108 Alcobendas (Madrid) |
| Hydrocortisone acetate | TIANJING TIANYAO PHARMACEUTICAL COM | China | PERFORMED | 2019 | 20/08/2019 | Nº 19 XINYE 9 STREET, WEST AREA OF TEDA TIANJING, 300462 CHINA |
| LEVOFLOXACIN | NEULAND (India) Unit II | INDIA | PERFORMED | 2019 | 29/08/2019 | Patancheru, telangana, India |
| Quetiapine Fumarate | MOEHS CANTABRIA | SPAIN (SAN) | PERFORMED | 2019 | 05/09/2019 | Pol. Industrial Requejada 39313 Polanco (Cantabria) |
| Metformin | SHOUGUAN FUKANG PHARMACEUTICAL CO. LTD | China | PERFORMED | 2019 | 03/09/2019 | North East of Dongwaihuan Road, Dongcheng Industrial Area, Shouguang City, Shandong Province, P.R. China |
| Oxyterracycline HCl and Oxyetracycline HCl micronized. | Hebei Shengxue Dacheng | China | PERFORMED | 2019 | 11/09/2019 | No.50 Shengxue Road, Luancheng district; Shijiazhuang, Hebei province, China No.17 Fuqiangxi Road, Luancheng district; Shijiazhuang, Hebei province, China |
| TROX20 Troxerutin. | EXPANSIA PCAS | FRANCE | PERFORMED | 2019 | 12/09/2019 | "PCAS Site : route Avignon 30390 Aramon " EUROPA |
| AIRPHARM | Spain | PERFORMED | 2019 | 12/09/2019 | Passeig de la Zona Franca 111, Torre Auditori, Planta 7, 08038 Barcelona-Spain | |
| ADRENALINE TARTRATE RACEPINEPHRINE HCL METRONIDAZOLE NORADRENALINE ACID TARTRATE | WUHAN WUYAO PHARMACEUTICAL CO LTD | China | PERFORMED | 2019 | 19/09/2019 | NO.18, WANGFEN ROAD,FUCHI TOWN, YANGXIN COUNTY, HUANGSHI CITY, HUBEI,PROVINCE,CHINA |
| Gynefam mamma | SWISSCAPS ROMANIA S.R.L. | Romania | PERFORMED | 2019 | 24/09/2019 | 1 Carol I Street; Cronu, Prahova, 107180 (Romania) |
| Laboratory analysis controller of: Pioglitazone Amlodipine Olmesartan-HCTZ | Laboratorio fundación DAU | Spain | PERFORMED | 2019 | 23/10/2019 | Carrer C, 12-14 P.I. Zona Franca 08040 Barcelona |
| API- Naproxen/Naproxen sodium | DIVI'S LABORATORIES LIMITED - UNIT II (Andhra Pradesh) | INDIA | PERFORMED | 2019 | 30/10/2019 | Annavaram Post Bheemunipatnam Mandal, Visahkapnam District, India - 531 162 Chippada Village, Andhra Pradesh |
| Nitroglycerin diluted 10%. | Copperhead Chemical Company | USA | PERFORMED | 2019 | 05/11/2019 | 120 River Road Tamaqua, PA 18252 USA |
| MUPIROCIN API AND ISOBUTYL ACETATE | TEVA PHARMA WORKS PRIVATE LIMITED COMPANY | Hungary | PERFORMED | 2019 | 12/11/2019 | Pallagi út 13, H-4042 Debrecen - Hungria |
| Riluzole | ALKEM | India | PERFORMED | 2019 | 13/11/2019 | |
| Transport | OLANO | FRANCE | PERFORMED | 2019 | 21/11/2019 | Z.I. du Breuil 52140 - Montigny FRANCE |
| ondansentron HCL | Qilu Pharmaceutical | China | PERFORMED | 2019 | 22/11/2019 | No 243 Gong Ye Bei Road, China-250 100 Jinan, Shandong Province |
| Galenic and analytical development | FAMAR | Spain | PERFORMED | 2019 | 27/11/2019 | Av. Leganés, 62, 28923 Alcorcón (Madrid) España |
| Cloxacillin sodium compacted and ampicillin-trih-densif | DSM ANTI-INFECTIVES (PUANJAB) | INDIA | PERFORMED | 2019 | 03/12/2019 | |
| Teicoplanin | DONGKOOK PHARMACEUTICAL | Korea | PERFORMED | 2019 | 16/12/2019 | |
| CARBOCYSTEINE | WUHAN GRAND HOYO CO. | China | PERFORMED | 2018 | 09/01/2018 | |
| CARBOXYCYSTEINE LYSINE SALT | ZHEJIANG SANMEN HENGKANG PHARMACEUTICAL CO. LTD | China | PERFORMED | 2018 | 11/01/2018 | |
| D-BIOTIN | ZHEJIANG SHENGDA BIO-PHARM | China | PERFORMED | 2018 | 12/01/2018 | |
| Magnesium Hydroxide | DUSLO | Slovakia | PERFORMED | 2018 | 24/01/2018 | |
| Sitagliptin Tartrate | SINTENOVO S.A | MEJICO | PERFORMED | 2018 | 29/01/2018 | CALLE 13 Este Nº3 CIVAC 62578 JIUTEPEC, MORELOS MEXICO |
| MOXIFLOX CHLORHID | YICHANG HEC CHANGJIANG PHARMACEUTICAL CO., LTD | China | PERFORMED | 2018 | 01/02/2018 | Nº 62 BINJIANG ROAD, CHINA-443300 YIDU CITY, HUBEI PROVINCE CHINA |
| Logistic operator | DHL FREIGHT SPAIN S.L | SPAIN (MAD) | PERFORMED | 2018 | 05/02/2018 | C/ Rumanía 4 28821 Coslada (Madrid) |
| Logistics operator | Logesta Gestión del transporte SAU | SPAIN (MAD) | PERFORMED | 2018 | 08/02/2018 | P.I Polvoranca C/ del Trigo 39 (28914) Leganés Madrid |
| Clozapine | SYNTON HISPANIA | SPAIN (BCN) | PERFORMED | 2018 | 13/02/2018 | Barcelona |
| Vaginal ring | Leon Pharma | SPAIN | PERFORMED | 2018 | 20/02/2018 | León |
| ALENDRONATE SODIUM | MEDICHEM | SPAIN | PERFORMED | 2018 | 01/03/2018 | Gerona |
| Castor oil | IHSEDU AGROCHEM PVT. LTD | India | PERFORMED | 2018 | 06/03/2018 | |
| Botulinum toxin | HUONS (Jecheon) | Korea | PERFORMED | 2018 | 06/03/2018 | 100, Bio valley-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea |
| Botulinum toxin | HUONS (Jecheon) | Korea | PERFORMED | 2018 | 07/03/2018 | 100, Bio valley-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea |
| Botulinum toxin clinical trial | C & R Research Inc | Korea | PERFORMED | 2018 | 08/03/2018 | Daechi MS Bldg., 412 Yeoksam-ro, Gangnam-gu, Seoul, Korea |
| Oxitril and Zolafren | ZAKLAD PHARMACEUTICZNY | Poland | PERFORMED | 2018 | 13/03/2018 | 33 Szkolna st., 95-054 Ksawerow |
| Oxitril and Zolafren | PABIANIKIE ZAKLADY | Poland | PERFORMED | 2018 | 13/03/2018 | Pi?sudskiego 5, Pabianice, Polonia |
| KLEPTOSE HPB PARENTAL GRADE | ZIBO QIANHUI BIOLOGICAL TECH. | China | PERFORMED | 2018 | 16/03/2018 | |
| Cartons in compact cardboard with offset printing | NECKICESA-Planta Sur | SPAIN | PERFORMED | 2018 | 20/03/2018 | Ctra. Navalcarnero a Chinchón, Km 21,200 28971 Griñón, Madrid - España |
| Injection-blow molded bottles/ PET bottles/ Extrusion-blow molded bottles/ Injection caps (desiccant option) | PLÁSTICOS INDEN | SPAIN | PERFORMED | 2018 | 22/03/2018 | Pol. Ind. LAlfaç III C/Ávila, 6, 03440 Ibi - ALICANTE, España |
| Norfloxacin | Zhejiang Neo Dankong Co Ltd | China | PERFORMED | 2018 | 22/03/2018 | 259 Binhai Road, Yantou Jiaojiang dist, Taizhou City, Zhejiang Province China CHINA |
| Norfloxacin | Zhejiang Neo Dankong Co Ltd | China | PERFORMED | 2018 | 22/03/2018 | 259 Binhai Road, Yantou Jiaojiang dist, Taizhou City, Zhejiang Province China CHINA |
| Famotidine | Cadila Healthcare | INDIA | PERFORMED | 2018 | 23/03/2018 | Plot No. 26 29 & 31, Dabhasa- Umaraya, Road VIII Dabhasa 391 |
| Secondary conditioning | FUNDACIÓN MANANTIAL | SPAIN (MAD) | PERFORMED | 2018 | 02/04/2018 | Pol. Ind. NEINOR HENARES Ferrocarril, 16. Edificio 3. Naves 23-24 28880 MECO - Madrid- |
| Dexketoprofen | Zhejiang Raybow Pharmaceutical Co. Ltd. | China | PERFORMED | 2018 | 04/04/2018 | No. 18 Nanyangsan Road, Linhai Zone, Taizhou City, Zhenjang Province China 317016 CHINA |
| Olanzapine | VIJAYSRI ORGANICS LIMITED | INDIA | PERFORMED | 2018 | 06/04/2018 | Plot Nº9, Jawaharlal Nehru Pharma city, Thadi Village, parawada mandal, Visakhapatnam district, 531021 Andhra Pradesh, India INDIA |
| Aromas of peach, blackberry, tangerine, etc. BLACKBERRY AROMA SOLUBLE TANGERINE AROMA/ESSENCE CREAM AROMA | I.F.F. Netherlands | Netherlands | PERFORMED | 2018 | 10/04/2018 | Zenenheuvelenweg 60, AN TILBURG 5048. HOLLAND |
| CRYSTAL MENTHOL | SHARP GLOBAL LIMITED | INDIA | PERFORMED | 2018 | 11/04/2018 | |
| Betaxolol HCl and Ipratropium | LUSOCHIMICA S.p.A | Italy | PERFORMED | 2018 | 19/04/2018 | |
| RITODRINE HYDROCHLORIDE | LUSOCHIMICA S.p.A | Italy | PERFORMED | 2018 | 19/04/2018 | Via Giotto 9 23871 Lomagna (LC) ITALY and Via Livornese 897 56010 La Vettola (PI) ITALY |
| Barium sulfate | HUNTSMAN PIGMENTS AND ADDITIVES | Germany | PERFORMED | 2018 | 24/04/2018 | Dr.-Rudolf-Sachtleben-Str. 4 47198 Duisburg, Nordrhein-Westfalen, Germany |
| Phenylephrine HCl | CHENG FONG | TAIWAN | PERFORMED | 2018 | 24/04/2018 | nº 19 Gong 4th Rd Dayuan Township. Taoyuan 337 Taiwan TAIWAN |
| Magnesium Hydroxide | DEAD SEA PERICLASE | Israel | PERFORMED | 2018 | 25/04/2018 | Magnesia products SBU, DEAD SEA PERICLASE_Industrial Zone, Mishor Rotem 8680600, Israel |
| Calcium Carbonate | Shanghai Nuo Cheng Pharmaceutical Co. Ltd. | China | PERFORMED | 2018 | 26/04/2018 | 1631 GU LANG ROAD, SHANGHAI, CHINA POST CODE: 200331 CHINA |
| Riluzole | SCINOPHARM Taiwan LTD | TAIWAN | PERFORMED | 2018 | 26/04/2018 | No. 1, Nan-Ke 8th Road, Tainan Science Industrial Park, Shan-Hua, Tainan 74144, Taiwan, China |
| Eslicarbazepine, Quetiapine fumarate, Solifenacin succinate | JUBILANT | INDIA | PERFORMED | 2018 | 02/05/2018 | |
| Aceclofenac | KOREA BIOCHEM PHARM. INC. | KOREA | PERFORMED | 2018 | 04/05/2018 | 204 Sandan-gil, Jeonui-myeon, Sejong-si, Korea (Rep. Ok) 339-853 |
| Phenazopyridine | Valens molecules private | INDIA | PERFORMED | 2018 | 10/05/2018 | VALENS MOLECULES PRIVATE LIMITED-UNIT-II (Formerly Posh Chemicals Private Limited) PLOT NO: 23, PHASE-I, ROAD NO: 13, IDA JEEDIMETLA, HYDERABAD - 500055 TELANGANA. INDIA |
| ISOPROPYL ALCOHOL, ALCOHOL, ACETONE | DISTRIBUIDOR OPPAC | SPAIN (PAM) | PERFORMED | 2018 | 10/05/2018 | Polígono Mocholi c/Noain 10, 31110 Noain (Navarra)" |
| TELMISARTAN | JIANGSU ZHONGBANG | China | PERFORMED | 2018 | 18/05/2018 | JIANGSU ZHONGBANG 36, SHUANGGAO ROAD, GAOCHUM, NANJING, JIANGSU, CHINA |
| 1) Dabigatran Etexilate Mesylate as active pharmaceutical ingredient. 2) 19TBPO - as an intermediate for the active pharmaceutical ingredient Rosuvastatin Calcium | TEVA | INDIA | PERFORMED | 2018 | 29/05/2018 | Plot Nos. Q1 to Q4 Industrial Area, Ghirongi Malanpur, Distt: Bhind (Madhya Pradesh) India |
| PVCs | Klöckner Pentaplast Schweiz AG | Switzerland | PERFORMED | 2018 | 29/05/2018 | Sportweg 38, Liebefeld, Bern (Switzerland) |
| MEMANTIN | INDUSTRIALE CHIMICA S.R.L. | Italy | PERFORMED | 2018 | 05/06/2018 | VIA E.H. GRIEG 13, 21047 SARONNO (VARESE) ITALIA |
| Salicylic acid | QUIMIDROGA | SPAIN (BCN) | PERFORMED | 2018 | 06/06/2018 | C/ Port de Lagos, 2-8 Muelle de Inflamables DELTA 1 08039 |
| Lacidofil capsules containing lyophilized bacteria | Lallemand Health Solutions | Canada | PERFORMED | 2018 | 07/06/2018 | (Institut Rosell manufacturing plant) 8480 Boul. St-Laurent MONTREAL, Qc. H2P 2M6 CANADA |
| Lacidofil capsules containing lyophilized bacteria | Lallemand Health Solutions | Canada | PERFORMED | 2018 | 07/06/2018 | (Institut Rosell manufacturing plant) 8480 Boul. St-Laurent MONTREAL, Qc. H2P 2M6 CANADA |
| Lacidofil capsules containing lyophilized bacteria | Lallemand Health Solutions | Canada | PERFORMED | 2018 | 07/06/2018 | (Institut Rosell manufacturing plant) 8480 Boul. St-Laurent MONTREAL, Qc. H2P 2M6 CANADA |
| Labels/ Leaflet labels | SINEL SYSTEMS, S.A. | SPAIN | PERFORMED | 2018 | 12/06/2018 | Avda. Castell de Barberà, 37-41, Centre Industrial Santiga 08210 Barberà del Vallès, Barcelona - SPAIN |
| DL-Methionine | EVONIK REXIM | China | PERFORMED | 2018 | 13/06/2018 | |
| GLYCINE (GLYCOCOLLA) | EVONIK REXIM | China | PERFORMED | 2018 | 14/06/2018 | No. 10 Wenjiang Road Wuming District, 530100 Nanning, Guangxi China |
| Donepezil and Risperidone | Zhejiang Huahai Licheng pharmaceutical Co Ltd | China | PERFORMED | 2018 | 14/06/2018 | Changshida'ao, Xunqiao Town (Linhai City, Zhejiang) China 317024 |
| PET containers | CAPSULIT- Gepack | PORTUGAL | PERFORMED | 2018 | 15/06/2018 | Rua 1º de Abril Edificio Gepack, 2050-182 AVEIRAS DE CIMA, Portugal |
| 13C Urea | CAMBRIDGE ISOTOPE LABORATORIES, INC. | USA | PERFORMED | 2018 | 28/06/2018 | 50 Frontage Road, Andover Tewksbury, MA 01810, United States of America |
| PVC coils | Klöckner Pentaplast | Germany | PERFORMED | 2018 | 12/07/2018 | Industrießstraße 3-5 56412 Heiligenroth, Germany |
| Leaflets | ZURITA | SPAIN (MAD) | PERFORMED | 2018 | 17/07/2018 | Polígono Ind. La Garena, C/ Ruperto Chapí 6, 28806 Alcalá de Henares, Madrid, España |
| Industrias Químicas Falcon de México, S.A | MEJICO | PERFORMED | 2018 | 17/07/2018 | Km. 4.5 Carretera Federal Cuernavaca-Cuautla, 62578 Jiutepec, Morelos, México; |
|
| Triamcinolone | NEWCHEM | Italy | PERFORMED | 2018 | 24/07/2018 | Via Roveggia, 47 37136 Verona (VR), Italy |
| Methylprednisolone Sodium | NEWCHEM | Italy | PERFORMED | 2018 | 24/07/2018 | Via Roveggia, 47 37136 Verona (VR), Italy |
| Aluminum | Aluberg | Italy | PERFORMED | 2018 | 25/07/2018 | Vía Rebecchi, 1, 24060- Bagnatica (BG) ITALY |
| Permethrin | Azico Biophore India Pvt Ltd. | India | PERFORMED | 2018 | 31/07/2018 | Azico Pharmaceuticals Pvt. Ltd. - Vizag Facility Located at Plot No. 40A, JN Pharmacity, Parawada Mandal, Visakhapatnam-531021, Andhra Pradesh, India |
| ZOLPIDEM HEMITARTRATRATE 100% | AARTI DRUGS LIMITED (MAHARASHTRA - INDIA) | India | PERFORMED | 2018 | 23/08/2018 | No. E22, MIDC, Tarapur, Tal. Palghar, Dist. Thane IND-401506 MAHARASHTRA INDIA |
| Vitamin D3 | XL Laboratories | India | PERFORMED | 2018 | 28/08/2018 | Works II A-141, EPIP, RIICO Industrial Area, Neemrana-301705, Rajasthan. India |
| Potassium | KLINGE CHEMICALS | UK | PERFORMED | 2018 | 04/09/2018 | 1 Bessemer Drive, Kelvin Industrial Estate (East Kilbridge, Glasgow) - G75 0QX - Reino Unido |
| Carbocisteine and Carbocysteine Lysine Salt | PHARMAZELL | INDIA | PERFORMED | 2018 | 05/09/2018 | Plot No.B5/B6, A1/A2, MEPZ, Tambaram, Chennai 600 045, India |
| Ciprofloxacin | ZHEJIANG GOUBANG PHARMACEUTICAL CO.LTD | China | PERFORMED | 2018 | 11/09/2018 | No.6 Weiwu Road. Hangzhou Gulf Shangyu Industrial Zone,Shangyu, Zhejiang province, China 312369 CHINA |
| CALCIUM FOLINATE | CERBIOS PHARMA | Switzerland | PERFORMED | 2018 | 12/09/2018 | Via figino, 6 (Barbengo), 6917 Lugano, Suiza |
| GLP | INFARMADE | SPAIN | PERFORMED | 2018 | 18/09/2018 | C/ Torre de los Herberos, 35. P.I. Carretera de la Isla. 41703 Dos Hermanas. Sevilla |
| RISO10 Risedronate Sodium D90<35 UQUIFA DOSU10 Doxylamine Succinate CICL10 Ciprofloxacin Hydrochloride Monohydrate ACIC10 Acyclovir RANI10 RANITIDINE COMPACTED RANITIDINE COMPACTED" RANITIDINE COMPACTED | Unión Químico Farmacéutica S.A. (UQUIFA) | SPAIN | PERFORMED | 2018 | 18/09/2018 | Pol. Moli de les Planes. Font de Bocs s/n C-35 Km 57 08470 San Celoni Barcelona |
| Ranitidine compacted | UQUIFA ESPAÑA | SPAIN | PERFORMED | 2018 | 19/09/2018 | Polígono Industrial El Pla. Av. Puigcerdà Nº 9, C-17, km 17,4, 08185 Lliçà de Vall-Barcelona ESPAÑA |
| Caps | ILHAPLAST - Sociedade Transformadora de Plásticos, S.A. | PORTUGAL | PERFORMED | 2018 | 20/09/2018 | Zona Industrial de Vagos, 3840 - 385 VAGOS |
| METAMIZOLE MAGNES SHANDONG | SHANDONG XINHUA PHARMACEUTICAL | China | PERFORMED | 2018 | 21/09/2018 | Hutian Chemical Industrial Zone, Zibo, Shandong, P.R.China |
| Vitamin D3 | Fermenta Biotech Limited | India | PERFORMED | 2018 | 26/09/2018 | Takoli, Himachal Pradesh 175121, India |
| Cartons in compact cardboard with offset printing | LECA GRAPHICS-Tipograf | SPAIN (MAD) | PERFORMED | 2018 | 17/10/2018 | Calle Sierra De Guadarrama, 48, 28830 Polígono De San Fernando De Henares |
| CASTOR OIL | HENRY LAMOTTE OILS GmbH | Germany | PERFORMED | 2018 | 17/10/2018 | Merkurstrasse, 47 28197 Bremen GERMANY |
| Lornoxicam | Optimus Drugs | INDIA | PERFORMED | 2018 | 23/10/2018 | 440, Tal Padra Dist. Vadodara, Gujarat, India |
| BIVALIRUDIN | AMBIOPHARM, INC (NORTH AUGUSTA-USA) | USA | PERFORMED | 2018 | 23/10/2018 | 1024 Dittman Court 29842 NORTH AUGUSTA, SOUTH CAROLINA USA |
| Analysis Raw Materials | Aquimisa Pharma | SPAIN | PERFORMED | 2018 | 24/10/2018 | c/ Hoces del Duratón 30-34 Pol. Ind El Montalvo II 37008 Salamanca |
| Type 1 glass vial | V. Santos | SPAIN (MAD) | PERFORMED | 2018 | 30/10/2018 | V.Santos Calle León, 55 P.I. Cobo Calleja Fuenlabrada (Madrid) C.P. 28947 |
| Logistics Operator | World courier | SPAIN | PERFORMED | 2018 | 06/11/2018 | Calle de Trespaderne, 29, 28042 Madrid Octubre 2018 |
| Plastic cans and lids | Berry Plastic Offranville | FRANCE | PERFORMED | 2018 | 08/11/2018 | BPREX Healthcare Offranville ZI du douxmesnil, 76550 Offranville, Francia |
| Clean Room Suits | ELIS MAGNOMATIC | SPAIN (MAD) | PERFORMED | 2018 | 13/11/2018 | C/ Londres 5. Pol. Ind. Torres de la Alameda 28814 TORRES DE LA ALAMEDA-MADRID |
| General audit | DIALTER | SPAIN | PERFORMED | 2018 | 19/11/2018 | Madrid |
| Granisetron 3 mg/ml | ZENTIVA SAGLIK/SANOFI | Turkey | PERFORMED | 2018 | 20/11/2018 | Pk 83-93 Kücükkaristiran- Lüleburgaz- Turkey 39780 Turquía |
| Eggs SPF | Valo Bio Media España | SPAIN | PERFORMED | 2018 | 22/11/2018 | Granja Rodríguez Serrano S.L. Finca La Verbena S/N 37800 Alba de Tormes (Salamanca) |
| Risperidone | CIPLA LTD Bangalore | INDIA | PERFORMED | 2018 | 23/11/2018 | Virgonagar Old Madrás Road 560 049 (Bangalore) India INDIA |
| Pantoprazole | CIPLA LTD Bangalore | INDIA | PERFORMED | 2018 | 23/11/2018 | Virgonagar Old Madrás Road 560 049 (Bangalore) India |
| ROCA10 Rosuvastatin FLCL10 Fluoxetine CLH TEVA "FLUT30 Flutamide Orion C Fermion (GAE) | ASSIA CHEMICAL INDUSTRIES | Israel | PERFORMED | 2018 | 27/11/2018 | TEVA TECH SITE Teva Tech site at Neot-Hovav Eco-Industrial Park, Emek Sara, P.O. Box 2049 Beer Sheva 8412316 Israel. |
| FLUT30 "FLUT30 Flutamide Orion C Fermion (GAE) | ORION CORPORATION FERMION | Finland | PERFORMED | 2018 | 12/12/2018 | Hanko plant, Orioninkatu 2, FI-10900 HANKO, FINLANDIA |
| FLCL30 Fluoxetine CH Fermion OY" "FLCL30 Fluoxetine CH Fermion OY | DIEPHEZ | FRANCE | PERFORMED | 2018 | 13/12/2018 | 6A, rue Munchhausen 67470 SELTZ FRANCE |
| Progesterone, Phenticonazole and FlUconazole soft capsule packaging. | Logista pharma | SPAIN | PERFORMED | 2018 | 19/12/2018 | C/Entre-rios nº 5, Polígono Industrial El Sebadal 35008 LAS PALMAS DE GRAN CANARIA |
| Logistic Operator | Cargill | SPAIN | documental audit | 2018 | send 27-12-18 | C/ Marie Curie 6 - 08760 Martorell (Barcelona) |
Our audit scope
GxP Audits
High-quality audits for GxP requirements that assess the level of compliance and implementation of customers and/or suppliers quality systems and outsourced activities.
GMP Audits (Good Manufacturing Practices)
- Supplier audits: Manufacturers of APIs, primary and secondary packaging materials, excipients, intermediate product, finished product.
- Audits for manufacturing laboratories (CMO).
- Audits for testing laboratories (quality control).
GDP Audits (Good Distribution Practices)
Audits for logistics operators (warehouses, distribution centres and carriers)
- API Distributor
- Excipient distributor
- Intermediate product or finished product distributor
- Intermediate warehouses.
GCP Audits (Good Clinical Practices)
- Audits for CRO.
- Sponsor of clinical trials.
GLP Audits (Good Laboratory Practices)
- Audits for preclinical development laboratories focused on research.
GVP Audits (Good Pharmacovigilance Practices)
- Internal audits of Pharmacovigilance Systems
- Support and assistance in inspections issued by the health authorities
- External audits of subsidiaries, partners and CROs
- In-person/remote audits
Clinical Analysis Laboratories Audits
- Audits of the quality management systems of Clinical Laboratories based on the requirements of standard UNE-EN-ISO 15189:2013.
Audits for Compliance of Medical Devices
- Audits of the quality management systems of manufacturers of medical devices based on the requirements of standard UNE-EN-ISO 13485:2016.
Medicinal Cannabis audits
- Audits of cannabis cultivation plants, manufacturers of their derivatives for medicinal purposes, and their warehouses and distribution centres.
Data Integrity Audits
- In the audit of this system, we assess the level of data integrity assurance at every stage of the process, verifying compliance with ALCOA principles in the management of manual and electronic records.
Internal Audits
- We put our experience and knowledge at the service of the industry to periodically examine its quality system and verify compliance with the standard.
- Our customers have the opportunity to identify areas for improvement to optimise their efforts and resources.
HOW WE WORK
Scheduling of audits:
- Collection of information and historical data to customise each audit according to the needs of our customers.
- Detection of deviations in the audited process.
- Preparation of a preliminary report at the start of the audit and delivery of a detailed final report.
- Review and monitoring of the CAPA plan.
- Design of a classification system and management of contractors based on risk to prioritise the audits and other assessable activities.
“Azierta Audit & Certification is your trusted partner to guarantee high quality and ensure regulatory compliance”.
Do You Need Assistance? Contact Our Experts
Just send us your questions & we will give you the help you need.