# FDA WARNING_LETTER - Merck KGaA - July 01, 2011

Source: https://www.keypedia.com/records/warning_letter/merck-kgaa/0bf4f20e-9b74-45f5-b7e2-2824aac26aec

> FDA WARNING_LETTER for Merck KGaA on July 01, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Merck KGaA
- Inspection Date: 2011-07-01
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Steven J. Lynn](https://www.keypedia.com/people/steven-j-lynn/23c7bb25-33be-48e2-81fd-ab34c6096eac)

Company: https://www.keypedia.com/companies/merck-kgaa/ae3fee38-0006-498d-b091-440c2c943be8

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c