FDA WARNING_LETTER - Larken Laboratories - December 31, 2009

FDA WARNING_LETTER for Larken Laboratories on December 31, 2009. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Larken Laboratories on December 31, 2009. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 331(a)

21 U.S.C. 321(g)

21 U.S.C. 355(b)

21 U.S.C. 352(f)(1)

21 CFR 201.5

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

21 U.S.C. 355(a)

21 CFR 201.115

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Record Information

Company

Larken Laboratories

Inspection Date

December 31, 2009

Product Type

Drugs

Office

New Orleans District Office

People

Tyler Thornburg (H.)

ID: 5f30710e-de5f-4c67-b896-78e51849f792

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