Areas cited
Aseptic processing and sterility assuranceDeviation, CAPA, and investigationLabeling and packagingDocumentation and recordsEquipment and facilityTraining and personnelLaboratory and QC controlsStability and storageContamination control
Published inspection documents
2024-01-17
US FDA
3 findingsDeviation, CAPA, and investigation · Labeling and packaging Written records of investigations into the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up .
2024-01-17
US FDA
15 findingsDeviation, CAPA, and investigation · Labeling and packaging · Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control · Documentation and records · Training and personnel · Equipment and facility · Stability and storage Written records are not made of investigations into unexplained discrepancies.
2024-01-17
US FDA
6 findingsEquipment and facility · Documentation and records · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds, insects, and other vermin.
2024-01-17
US FDA
5 findingsAseptic processing and sterility assurance · Labeling and packaging Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
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.
