FDA WARNING_LETTER - NuGeneration Technologies LLC - September 22, 2022

FDA WARNING_LETTER for NuGeneration Technologies LLC on September 22, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for NuGeneration Technologies LLC on September 22, 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 211.166(a)

21 CFR 211

21 CFR 211.165(a)

21 CFR 210

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

21 CFR 211.84(d)(1)

21 CFR 211.84(d)(2)

21 CFR 211.34

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Record Information

Company

NuGeneration Technologies LLC

Inspection Date

September 22, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations IV

People

ID: 2a7ecd6a-477c-47fc-8bd6-8c1d342ad846

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