Areas cited
Quality unit oversightDeviation, CAPA, and investigationProcess validationOther quality systemEquipment and facilityComputer system validationDocumentation and recordsLaboratory and QC controls
Published inspection documents
2024-04-05
US FDA
4 findingsProcess validation · Deviation, CAPA, and investigation · Quality unit oversight Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
2022-10-25
US FDA
6 findingsQuality unit oversight · Deviation, CAPA, and investigation · Documentation and records · Other quality system The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
2022-06-06
Health Canada
7 findingsEquipment and facility · Quality unit oversight · Other quality system · Computer system validation The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The preventative maintenance and repair of the equipment was inadequate.
2021-08-17
US FDA
7 findingsDeviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Process validation · Computer system validation · Quality unit oversight Investigations of any unexplained discrepancy, a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
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.
