Areas cited
Aseptic processing and sterility assuranceDeviation, CAPA, and investigationProcess validationTraining and personnelRegulatory reporting and change controlDocumentation and recordsValidation and qualificationEquipment and facilityLaboratory and QC controlsLabeling and packagingQuality unit oversight
Published inspection documents
2026-05-08
US FDA
3 findingsLaboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
2025-07-01
US FDA
17 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Validation and qualification · Process validation · Training and personnel · Documentation and records Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
2024-11-05
US FDA
9 findingsProcess validation · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel · Regulatory reporting and change control · Quality unit oversight · Labeling and packaging Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or 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.
