FDA WARNING_LETTER - Apollo Care, LLC - March 27, 2025

FDA WARNING_LETTER for Apollo Care, LLC on March 27, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Apollo Care, LLC on March 27, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.67(a)

21 U.S.C. 353b(d)(4)

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

FD&C Act 501

21 U.S.C. 353b

FD&C Act 301(k)

21 U.S.C. 331(k)

21 CFR 211

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

21 CFR 210

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Record Information

Company

Apollo Care, LLC

Inspection Date

March 27, 2025

Product Type

drugs

Office

Office of Compounding Quality and Compliance

People

Matthew J. Lash (Acting Director)

ID: 1259d49f-a767-4776-9135-2cf094b21ccd

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