FDA WARNING_LETTER - Omega Packaging Corp - November 17, 2022

FDA WARNING_LETTER for Omega Packaging Corp on November 17, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Omega Packaging Corp on November 17, 2022. 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 211.22

21 CFR 211.84(d)(1)

21 CFR 211.84(d)(2)

21 CFR 211.34

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Record Information

Company

Omega Packaging Corp

Inspection Date

November 17, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Lisa M. Harlan (Program Division Director)

ID: bc18fc71-e16a-4819-ba01-5a50ded07e0c

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