Areas cited
Equipment and facilityMaterial and supplier controlDeviation, CAPA, and investigationQuality unit oversight
Published inspection documents
2024-05-21
US FDA
4 findingsEquipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Material and supplier control Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your firm manufactured over-the-counter (OTC) hand sanitizer drug products on equipment also used to manufacture non-pharmaceutical products, including industrial chemicals such as floor cleaner. It is unacceptable as a matter of CGMP to manufacture drugs using the same equipment that you use to manufacture these non-pharmaceutical products due…
2024-05-14
US FDA
4 findingsQuality unit oversight · Equipment and facility · Deviation, CAPA, and investigation · Material and supplier control Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm’s quality system was inadequate. Specifically, your firm was unable to demonstrate that your QU had the responsibility and authority to ensure critical elements of drug product manufacturing operations were adequately controlled…
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.
