FDA WARNING_LETTER - Merck KGaA - July 01, 2011

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The FDA issued a Warning Letter to Merck KGaA following inspections of three facilities: MS-Corsier-sur-Vevey (API manufacturing, June 2011), MS-Aubonne (finished drug manufacturing, June 2011), and MS-Tiburtina (product testing, June-July 2011).

Significant deviations from Current Good Manufacturing Practice (CGMP) and violations of 21 C.F.R. § 601.12 (reporting changes to approved applications) were identified at MS-Corsier-sur-Vevey. Violations at MS-Aubonne and MS-Tiburtina included CGMP for Finished Pharmaceuticals (21 C.F.R. Parts 210 and 211), 21 C.F.R. § 600.14(c) (Biological Product Deviation Report submission), and 21 C.F.R. § 601.12. These violations render products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Specific violations included: - **MS-Corsier-sur-Vevey:** Failure to report changes to product/process, such as adding a new API process to a dedicated suite. - **MS-Aubonne:** Inadequate procedures to prevent microbial contamination (deficient media fill program, lack

Company: Merck KGaA
Inspection Date: July 1, 2011
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Steven J. Lynn

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ID · 0bf4f20e-9b74-45f5-b7e2-2824aac26aec

Violation Codes10

21 U.S.C. 351(a)(2)(B)21 CFR 601.1221 CFR 21021 CFR 21121 CFR 600.14(c)FD&C Act 501(a)(2)(B)FD&C Act 801(a)(3)21 CFR 211.113(b)21 CFR 211.19821 CFR 211.160(b)

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