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# Warning Issued to German OTC Drug Maker Over GMPs
- URL: https://www.fdaweb.com/warning-issued-to-german-otc-drug-maker-over-gmps/
- Published: 2022-09-27T12:00:00.000Z
- Updated: 2026-09-14T18:00:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152829

FDA has issued a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/system-kosmetik-produktionsgesellschaft-fur-kosmetische-gmbh-632727-09092022?ref=fdaweb.com) to German over-the-counter drug manufacturer System Kosmetik Produktionsgesellschaft fur kosmetische after inspecting the firm in February and citing GMP deviations. The letter says the firm failed to establish adequate written procedures for production and process controls, and provide data to demonstrate that the manufacturing processes have been validated. The company also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, containers, closures, in-process materials, labeling, and drug products conform to appropriate standards. Additionally, it failed to test incoming active pharmaceutical ingredients used to manufacture its drug products to determine their identity.