FDA WARNING_LETTER - atlantic management resources ltd - August 10, 2022

FDA WARNING_LETTER for atlantic management resources ltd on August 10, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for atlantic management resources ltd on August 10, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(a)(2)(B)

FD&C Act 502(o)

21 U.S.C. 331(a)

21 CFR 211

21 U.S.C. 360(d)

21 CFR 211.188(b)

21 CFR 210

21 CFR 211.22(a)

FD&C Act 301(a)

21 U.S.C. 360(i)

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Record Information

Company

atlantic management resources ltd

Inspection Date

August 10, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Lisa M. Harlan (Program Division Director)

ID: ea4c5f27-21b9-4367-9cc3-8b4f2865849e

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