FDA WARNING_LETTER - McNeil Consumer and Specialty Pharmaceuticals - January 08, 2010

FDA WARNING_LETTER for McNeil Consumer and Specialty Pharmaceuticals on January 08, 2010. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for McNeil Consumer and Specialty Pharmaceuticals on January 08, 2010. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 314.81(b)(1)(ii)

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

21 CFR 211

21 U.S.C. 355(k)

21 CFR 210

21 CFR 211.192

21 U.S.C. 351(a)(2)(B)

21 CFR 211.198

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Record Information

Company

McNeil Consumer and Specialty Pharmaceuticals

Inspection Date

January 8, 2010

Product Type

Drugs

Office

San Juan District Office

People

ID: 90de1ac4-f510-49cc-af3b-beb20606abb8

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