FDA WARNING_LETTER - Ultra Chem Labs Corporation - July 27, 2022

FDA WARNING_LETTER for Ultra Chem Labs Corporation on July 27, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Ultra Chem Labs Corporation on July 27, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 352(j)

21 U.S.C. 321(p)

21 U.S.C. 352(e)(1)(A)

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 U.S.C. 352(a)

21 CFR 211

21 U.S.C. 321(g)(1)(B)

21 CFR 211.165(a)

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Record Information

Company

Ultra Chem Labs Corporation

Inspection Date

July 27, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations IV

People

Steven E. Porter (Program Division Director)

ID: 442425fe-cb2a-4a9e-9858-c43a78465381

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