GRMGlobal Regulatory Monitor 한국어 This week

By Document

US FDA · 2016

11 inspection documents published by US FDA in 2016. Open a document to see every finding from that inspection.

Zhejiang Medicine Co.Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation 2016-12-15 4 findings Aurobindo Pharma Limited Unit 4Laboratory and QC controls · Process validation · Other quality system 2016-12-15 3 findings Sun Pharmaceutical Industries Ltd.Stability and storage · Training and personnel · Quality unit oversight · Complaint and recall handling · Other quality system · Laboratory and QC controls 2016-12-13 8 findings Teva Pharmaceutical Works Private Limited CompanyDeviation, CAPA, and investigation · Complaint and recall handling · Aseptic processing and sterility assurance · Laboratory and QC controls · Documentation and records · Material and supplier control · Equipment and facility · Computer system validation 2016-11-29 11 findings Alembic Pharmaceuticals LimitedDeviation, CAPA, and investigation · Contamination control · Process validation · Quality unit oversight 2016-11-29 4 findings Lupin LimitedDeviation, CAPA, and investigation · Equipment and facility · Contamination control · Material and supplier control · Other quality system · Laboratory and QC controls · Process validation 2016-11-29 9 findings Sanofi Winthrop IndustrieEquipment and facility · Complaint and recall handling · Deviation, CAPA, and investigation · Validation and qualification · Other quality system · Material and supplier control · Aseptic processing and sterility assurance · Regulatory reporting and change control 2016-11-29 11 findings Claris Injectables LimitedOther quality system · Training and personnel · Process validation · Aseptic processing and sterility assurance · Quality unit oversight 2016-11-29 5 findings Cipla LimitedComplaint and recall handling · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2016-11-29 4 findings Indoco Remedies LimitedComplaint and recall handling · Quality unit oversight · Equipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2016-11-29 6 findings Alkem Laboratories LimitedQuality unit oversight · Equipment and facility · Deviation, CAPA, and investigation · Stability and storage · Laboratory and QC controls · Other quality system · Complaint and recall handling · Contamination control 2016-11-29 11 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.