FDA WARNING_LETTER - Dextrum Laboratories Inc. - July 18, 2023

FDA WARNING_LETTER for Dextrum Laboratories Inc. on July 18, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Dextrum Laboratories Inc. on July 18, 2023. 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 211.84(d)(1)

21 CFR 211.84(d)(6)

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Record Information

Company

Dextrum Laboratories Inc.

Inspection Date

July 18, 2023

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

Ronda Loyd-jones (Director of Compliance Branch)

ID: 70960935-81af-49dc-99ae-c3a2ca512f89

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