FDA WARNING_LETTER - Diamond Chemical Co., Inc. - May 16, 2024

FDA WARNING_LETTER for Diamond Chemical Co., Inc. on May 16, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Diamond Chemical Co., Inc. on May 16, 2024. 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

Diamond Chemical Co., Inc.

Inspection Date

May 16, 2024

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Lisa M. Harlan (Program Division Director)

ID: 707f2fed-94f9-4088-b92e-d6669de30b6a

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