By Document

US FDA · 2017

25 inspection documents published by US FDA in 2017. Open a document to see every finding from that inspection.

Shilpa Medicare LimitedOther quality system · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Quality unit oversight · Laboratory and QC controls 2017-12-08 9 findings Glenmark Pharmaceuticals Ltd.Quality unit oversight · Process validation · Complaint and recall handling · Computer system validation · Training and personnel 2017-12-05 6 findings Claris Injectables Ltd.Other quality system · Equipment and facility · Quality unit oversight · Laboratory and QC controls · Environmental monitoring · Validation and qualification · Aseptic processing and sterility assurance · Data integrity 2017-10-19 15 findings Divi's Laboratories Ltd. Unit IILaboratory and QC controls · Other quality system · Deviation, CAPA, and investigation · Documentation and records 2017-09-26 4 findings Dr. Reddy's Laboratories Ltd.Material and supplier control · Cleaning validation · Other quality system 2017-09-26 3 findings Biocon Ltd.Training and personnel · Laboratory and QC controls · Quality unit oversight · Aseptic processing and sterility assurance · Labeling and packaging · Deviation, CAPA, and investigation 2017-08-03 9 findings Intas PharmaceuticalsQuality unit oversight · Equipment and facility · Laboratory and QC controls · Contamination control · Training and personnel 2017-07-19 7 findings Zhejiang Bangli Medical Products Co.Labeling and packaging · Other quality system · Training and personnel · Equipment and facility · Process validation · Documentation and records 2017-07-07 7 findings Lupin Limited Unit IIIDeviation, CAPA, and investigation · Computer system validation · Quality unit oversight · Laboratory and QC controls · Process validation 2017-06-29 5 findings Strides Shasun LimitedDeviation, CAPA, and investigation · Laboratory and QC controls · Process validation 2017-06-05 3 findings Lupin LimitedDeviation, CAPA, and investigation · Equipment and facility · Process validation · Documentation and records 2017-06-02 6 findings Sekisui MedicalOther quality system · Cleaning validation · Process validation · Laboratory and QC controls · Equipment and facility 2017-05-16 10 findings Torrent Pharmaceuticals LimitedOther quality system · Quality unit oversight · Laboratory and QC controls 2017-05-11 3 findings Badrivishal Chemicals & PharmaceuticalsEquipment and facility · Laboratory and QC controls · Computer system validation · Training and personnel 2017-05-11 7 findings Cosma SpAOther quality system · Material and supplier control · Cleaning validation · Training and personnel · Equipment and facility · Documentation and records · Stability and storage 2017-05-11 11 findings Biocon LimitedOther quality system · Deviation, CAPA, and investigation 2017-05-09 5 findings Aurobindo Pharma Ltd. Unit IVComputer system validation · Other quality system · Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance 2017-05-08 7 findings Dr. Reddy's LaboratoriesQuality unit oversight · Laboratory and QC controls · Material and supplier control · Training and personnel · Equipment and facility · Computer system validation 2017-05-04 9 findings Aurobindo Pharm Ltd. Unit 3Laboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight 2017-05-02 6 findings Sun Pharmaceutical Industries Ltd.Other quality system · Training and personnel · Equipment and facility · Documentation and records · Quality unit oversight · Complaint and recall handling · Deviation, CAPA, and investigation 2017-04-21 10 findings Bayer AG PharmaEquipment and facility · Deviation, CAPA, and investigation · Other quality system · Contamination control · Complaint and recall handling · Laboratory and QC controls 2017-02-22 9 findings Natco Pharma LimitedQuality unit oversight · Aseptic processing and sterility assurance · Stability and storage · Complaint and recall handling · Laboratory and QC controls 2017-02-01 5 findings CP PharmaceuticalsQuality unit oversight · Laboratory and QC controls · Process validation · Training and personnel · Aseptic processing and sterility assurance · Complaint and recall handling · Material and supplier control · Stability and storage · Equipment and facility 2017-01-27 13 findings Wockhardt LimitedEquipment and facility · Aseptic processing and sterility assurance · Computer system validation · Deviation, CAPA, and investigation · Quality unit oversight · Validation and qualification · Other quality system 2017-01-26 8 findings Hetero Labs LimitedComputer system validation · Complaint and recall handling · Deviation, CAPA, and investigation · Quality unit oversight · Documentation and records · Equipment and facility 2017-01-13 7 findings

These findings are a record of the moment each document was published. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out — do not read them as the current state; check the regulator's official announcements for the latest status. The list includes documents with three or more findings, except for agencies whose documents carry a single finding each (EU/UK GMP non-compliance reports), where that threshold is not applied. Other documents can be found in Findings search. Each document links directly to the source the regulator published.