FDA 483 - Johnson Matthey Inc. (dba Johnson Matthey Pharm. Materials) - August 27, 2015

Johnson Matthey Inc. (dba Johnson Matthey Pharmaceutical Materials) in Conshohocken, PA, was cited for significant deficiencies across its manufacturing and quality systems. Observations included inadequate equipment cleaning and maintenance, a deficient Quality Unit lacking proper procedures for investigations and internal audits, and incomplete investigations into manufacturing discrepancies. Additionally, the firm failed to consistently use its change control system and demonstrated inadequate materials management and inventory controls.