Areas cited
Aseptic processing and sterility assuranceDeviation, CAPA, and investigationProcess validationTraining and personnelDocumentation and recordsValidation and qualificationLaboratory and QC controlsComputer system validationLabeling and packagingQuality unit oversightEnvironmental monitoring
Published inspection documents
2026-01-16
US FDA
4 findingsDeviation, CAPA, and investigation · Computer system validation · Aseptic processing and sterility assurance · Laboratory and QC controls Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
2025-05-13
US FDA
20 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Documentation and records · Validation and qualification · Training and personnel · Environmental monitoring Your facility’s drug products, such as Prednisolone Phosphate 1% Moxifloxacin 0.5% 5ml Sterile Ophthalmic Solution and Atropine Sulfate 0.025% 3.5ml Sterile Ophthalmic Solution, did not include the following on the label: a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.
2024-11-21
US FDA
6 findingsLabeling and packaging · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight The container of your outsourcing facility's drug products does not include information required b y section 503B(a)(10)(B) of the Federal Food, Drug, 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.
