Areas cited
Process validationTraining and personnelOther quality systemAseptic processing and sterility assuranceDocumentation and recordsEquipment and facilityLaboratory and QC controlsMaterial and supplier controlDeviation, CAPA, and investigationLabeling and packagingQuality unit oversightRegulatory reporting and change controlContamination controlEnvironmental monitoring
Published inspection documents
2026-03-03
US FDA
31 findingsLaboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Quality unit oversight · Material and supplier control · Other quality system · Environmental monitoring · Labeling and packaging · Process validation · Contamination control · Documentation and records · Deviation, CAPA, and investigation · Training and personnel Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
2025-09-04
US FDA
16 findingsAseptic processing and sterility assurance · Material and supplier control · Regulatory reporting and change control · Quality unit oversight · Other quality system · Labeling and packaging · Documentation and records · Process validation · Laboratory and QC controls · Training and personnel · Equipment and facility · Deviation, CAPA, and investigation Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
