Areas cited
Aseptic processing and sterility assuranceEquipment and facilityDeviation, CAPA, and investigationOther quality systemProcess validationTraining and personnelContamination control
Published inspection documents
2024-01-17
US FDA
10 findingsEquipment and facility · Aseptic processing and sterility assurance · Process validation · Contamination control · Training and personnel · Deviation, CAPA, and investigation Routine calibration of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
2019-11-14
US FDA
5 findingsAseptic processing and sterility assurance · Equipment and facility · Other quality system · Deviation, CAPA, and investigation Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
2019-04-30
US FDA
5 findingsOther quality system · Deviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance There are no written procedures for production and process confirms designed to assure that the drug products have the identity, strength, quality, and purity they purport are represented to possess.
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.
