By Document
US FDA · 2018
28 inspection documents published by US FDA in 2018. Open a document to see every finding from that inspection.
Dishman Carbogen Amcis Ltd.Deviation, CAPA, and investigation · Other quality system
2018-12-10
3 findings
Gadea Biopharma S.L.Other quality system · Equipment and facility · Labeling and packaging
2018-12-04
6 findings
Dr. Reddy's Laboratories LimitedDeviation, CAPA, and investigation · Training and personnel · Aseptic processing and sterility assurance · Documentation and records
2018-11-14
5 findings
Lupin Limited Unit IIIOther quality system · Material and supplier control · Computer system validation · Equipment and facility · Process validation
2018-11-05
5 findings
Liva Pharmaceuticals Ltd.Other quality system · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation
2018-09-10
4 findings
Sun Pharmaceutical Industries LtdLaboratory and QC controls · Stability and storage · Contamination control · Quality unit oversight · Process validation
2018-09-10
5 findings
Yuki Gosei Kogyo Co. Ltd.Laboratory and QC controls · Material and supplier control · Quality unit oversight · Equipment and facility · Other quality system
2018-09-10
7 findings
Unichem Laboratories Ltd.Stability and storage · Cleaning validation · Laboratory and QC controls
2018-09-10
4 findings
Zhejiang Huahai Pharmaceutical Co. Ltd.Aseptic processing and sterility assurance · Equipment and facility · Other quality system · Laboratory and QC controls
2018-08-09
4 findings
Hetero Drugs Ltd. Unit 1Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight · Training and personnel
2018-07-17
5 findings
Hospira Healthcare IndiaAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Process validation · Complaint and recall handling · Quality unit oversight · Equipment and facility
2018-07-11
10 findings
Galaxy Surfactants Ltd.Stability and storage · Other quality system · Training and personnel · Cleaning validation · Equipment and facility · Documentation and records · Quality unit oversight
2018-06-28
9 findings
Mylan Laboratories Ltd.Data integrity · Computer system validation · Material and supplier control · Laboratory and QC controls · Complaint and recall handling · Equipment and facility
2018-06-26
6 findings
Galaxy Surfactants Ltd.Cleaning validation · Stability and storage · Training and personnel · Quality unit oversight
2018-06-26
4 findings
Glenmark Pharmaceuticals Ltd.Laboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight
2018-06-05
4 findings
Suven Life Sciences Ltd.Other quality system · Documentation and records · Material and supplier control · Labeling and packaging · Training and personnel · Equipment and facility
2018-05-24
6 findings
Auronext PharmaLaboratory and QC controls · Training and personnel · Process validation
2018-05-17
3 findings
Biocon Ltd.Other quality system · Cleaning validation · Equipment and facility · Laboratory and QC controls · Environmental monitoring · Material and supplier control
2018-05-17
7 findings
Akorn AGStability and storage · Equipment and facility · Laboratory and QC controls
2018-05-03
3 findings
Cipla Ltd.Process validation · Laboratory and QC controls · Stability and storage
2018-04-20
3 findings
Alkem Laboratories Ltd.Quality unit oversight · Other quality system · Process validation · Equipment and facility · Laboratory and QC controls · Stability and storage
2018-04-11
10 findings
Cipla Ltd.Material and supplier control · Quality unit oversight · Laboratory and QC controls · Equipment and facility
2018-03-27
7 findings
Dr. Reddy's Laboratories Ltd.Complaint and recall handling · Material and supplier control · Equipment and facility
2018-03-21
3 findings
Biocon Sdn BhdAseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Process validation
2018-03-12
6 findings
Sun Pharmaceutical Industries Ltd.Other quality system · Aseptic processing and sterility assurance · Equipment and facility
2018-03-06
3 findings
Aurobindo Pharma Ltd.Equipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance · Computer system validation · Training and personnel
2018-03-06
8 findings
Indoco RemediesStability and storage · Laboratory and QC controls · Quality unit oversight · Documentation and records · Labeling and packaging · Equipment and facility
2018-02-15
7 findings
Daewoong Pharmaceutical Co. Ltd.Aseptic processing and sterility assurance · Process validation · Training and personnel · Material and supplier control · Computer system validation
2018-01-22
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.
