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.
