FDA EIR - R. Mason (Chemicals), Ltd. - July 21, 2016

An FDA inspection of R. Mason (Chemicals), Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in the United Kingdom, was conducted from July 18-21, 2016. The inspection, which focused on cGMP compliance for their API product distributed to the U.S. market, identified four significant issues. The main violations included the absence of an ongoing stability program to support the expiry period listed on product Certificates of Analysis. Additionally, the company had not performed cleaning validation for its manufacturing operations, and reprocessed vacuumed material without assessing its equivalency to normal production batches. A third finding concerned the lack of validation for raw material Certificates of Analysis, with only identification tests being performed. Finally, the inspection revealed inadequate record-keeping for primary packaging material lot numbers in batch records, hindering traceability. These observations highlighted areas of non-compliance with the regulatory framework governing drug manufacturing. Management acknowledged the findings, committing to correct all identified deficiencies and to provide a written response to the FDA.