Areas cited
Aseptic processing and sterility assuranceMaterial and supplier controlDeviation, CAPA, and investigationRegulatory reporting and change controlOther quality systemDocumentation and recordsEquipment and facilityComputer system validationLabeling and packaging
Published inspection documents
2025-03-25
US FDA
11 findingsMaterial and supplier control · Aseptic processing and sterility assurance · Computer system validation · Deviation, CAPA, and investigation · Documentation and records · Equipment and facility Your firm provided several updated written procedures with your responses; however, they appear to be in draft form as the approval signature manifests are incomplete. Therefore, the effective date of these revised procedures cannot be verified. In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug…
2024-10-02
US FDA
7 findingsLabeling and packaging · Deviation, CAPA, and investigation · Other quality system · Regulatory reporting and change control · Aseptic processing and sterility assurance · Material and supplier control The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Dmg, and Cosmetic Act (FD&C Act).
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.
