FDA WARNING_LETTER - Merck & Company, Inc. - January 17, 2008

FDA WARNING_LETTER for Merck & Company, Inc. on January 17, 2008. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Merck & Company, Inc. on January 17, 2008. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

FD&C Act 501(a)(2)(B)

21 CFR 211.68(a)

21 CFR 211.160(b)

21 CFR 211

21 CFR 211.68(b)

21 CFR 210

21 CFR 211.192

21 CFR 211.160(a)

21 CFR 211.198

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Record Information

Company

Merck & Company, Inc.

Inspection Date

January 17, 2008

Product Type

Biologics

Office

Office of Compliance and Enforcement

People

David K. Elder (Principal)

ID: 93ed085d-29d1-4367-a730-468a32b3b4f9

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