Areas cited
Aseptic processing and sterility assuranceDeviation, CAPA, and investigationOther quality systemEquipment and facilityLaboratory and QC controlsProcess validationTraining and personnelDocumentation and recordsCleaning validationMaterial and supplier controlComputer system validationQuality unit oversight
Published inspection documents
2025-06-20
US FDA
7 findingsAseptic processing and sterility assurance · Documentation and records · Computer system validation · Deviation, CAPA, and investigation · Other quality system Procedures designed to prevent microbiological contamination of diug products purpo1iing to be sterile did not include adequate validation of the aseptic process.
2023-08-14
US FDA
6 findingsAseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation · Material and supplier control · Other quality system · Laboratory and QC controls Procedures designed to prevent microbiological contamination of diug products purpo1i ing to be sterile are not established, written, or followed.
2021-10-25
US FDA
4 findingsEquipment and facility · Other quality system · Cleaning validation Facilities and equipment are not adequately validated and maintained for .__~~~~~~~~~~___, manufacture.
2020-04-02
US FDA
3 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight Procedures designed to prevent microbiological contamination of diug products purpo1iing to be sterile are not established and followed.
2018-03-12
US FDA
6 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Process validation Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established or followed.
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.
