FDA 483 - System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh - February 18, 2022

An FDA inspection of System Kosmetik Produktionsgesellschaft mbH in Munster, Germany, a drug product manufacturer, revealed significant deficiencies across multiple areas. The firm lacked adequate written procedures for production and process controls, failed to establish scientifically sound laboratory controls and specifications, and did not properly qualify manufacturing equipment. Additionally, issues with data integrity, equipment surface integrity, raw material identity verification, and equipment log maintenance were observed, indicating a broad lack of control over critical manufacturing processes.