Areas cited
Deviation, CAPA, and investigationOther quality systemLaboratory and QC controlsQuality unit oversightProcess validationDocumentation and recordsComplaint and recall handlingEquipment and facilityStability and storage
Published inspection documents
2024-01-17
US FDA
3 findingsComplaint and recall handling · Other quality system · Laboratory and QC controls Procedures describing the handling of all WTitten and oral complaints regarding a drug product are not followed.
2024-01-17
US FDA
3 findingsOther quality system · Deviation, CAPA, and investigation · Process validation Procedures describing the warehousing of drug products are not established and followed Specifically, the firm failed to follow the section 7.9.1.3" (b)(4) (b)(4) * DATES OF INSPECTION: IOIl4 /20 10(Thu), IO/1 5/201 0(Fri), IO/1 912 010(Tue), IO/21 /2010(Thu) EMPLO YEEIS ) SIG NA...
2024-01-17
US FDA
4 findingsDocumentation and records · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation Master production and control records Jack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required.
2023-12-12
Health Canada
4 findingsDeviation, CAPA, and investigation · Quality unit oversight · Equipment and facility · Stability and storage Investigations into deviations, reports, and/or follow-up actions were inadequate.
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.
