Areas cited
Aseptic processing and sterility assuranceDocumentation and recordsDeviation, CAPA, and investigationTraining and personnelProcess validationEquipment and facilityMaterial and supplier control
Published inspection documents
2025-03-11
US FDA
7 findingsDeviation, CAPA, and investigation · Material and supplier control · Equipment and facility · Aseptic processing and sterility assurance · Documentation and records · Process validation There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
2019-04-30
US FDA
5 findingsDocumentation and records · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel The batch production and control records are deficient in that they do not include documentation of the accomplishment ofeach significant step in manufacturing, processing, packing and holding.
2019-04-30
US FDA
5 findingsDocumentation and records · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel The batch production and control records are deficient in that they do not include documentation of the accomplishment ofeach significant step in manufacturing, processing, packing and holding.
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.
