FDA 483 - R. Mason (Chemicals), Ltd. - July 21, 2016

An FDA inspection of R. Mason (Chemicals) Ltd., an API manufacturer in the United Kingdom, revealed significant deficiencies in their quality systems. The firm lacked an ongoing stability program for its API product, failed to validate cleaning procedures, and did not validate Certificates of Analysis for raw materials. Additionally, the company did not maintain adequate records for primary packaging material traceability.