Areas cited
Aseptic processing and sterility assuranceOther quality systemEquipment and facilityProcess validationTraining and personnelComplaint and recall handlingLaboratory and QC controlsStability and storageContamination controlDeviation, CAPA, and investigationQuality unit oversightDocumentation and recordsMaterial and supplier controlComputer system validationEnvironmental monitoring
Published inspection documents
2024-01-17
US FDA
21 findingsAseptic processing and sterility assurance · Other quality system · Quality unit oversight · Laboratory and QC controls · Stability and storage · Complaint and recall handling · Training and personnel · Documentation and records · Material and supplier control · Process validation Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
2024-01-17
US FDA
13 findingsOther quality system · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Training and personnel · Equipment and facility · Complaint and recall handling · Stability and storage · Laboratory and QC controls on the FDA 483 dated 07!16/13.
2024-01-17
US FDA
10 findingsEquipment and facility · Deviation, CAPA, and investigation · Process validation · Aseptic processing and sterility assurance · Computer system validation · Quality unit oversight Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
2024-01-17
US FDA
6 findingsOther quality system · Equipment and facility · Environmental monitoring · Contamination control · Aseptic processing and sterility assurance Non-depyrogenated containers were used in drug production.
2024-01-17
US FDA
6 findingsAseptic processing and sterility assurance · Other quality system · Contamination control Your firm continued producing sterile drug products while construction was ongoing within your facility without establishing adequate controls to prevent contamination of the production environment.
About this page
This is a record of that moment. 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 it as the current state; check the regulator's official announcements for the latest status.
What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.
Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.
