FDA WARNING_LETTER - Winder Laboratories, LLC - July 18, 2018

FDA WARNING_LETTER for Winder Laboratories, LLC on July 18, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Winder Laboratories, LLC on July 18, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

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

21 CFR 211

21 CFR 210

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

21 CFR 211.67(b)

21 CFR 211.34

21 CFR 211.194(a)

21 U.S.C. 356C(b)

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Record Information

Company

Winder Laboratories, LLC

Inspection Date

July 18, 2018

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

Monica R. Maxwell (Program Division Director)

ID: b5308ae8-a871-4627-99bf-9cd705a3b2fc

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