FDA WARNING_LETTER - MedisourceRx - June 10, 2025

FDA WARNING_LETTER for MedisourceRx on June 10, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for MedisourceRx on June 10, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(d)

FD&C Act 301(d)

21 U.S.C. 353b(a)(1)

21 U.S.C. 321(p)

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

21 U.S.C. 353b(b)(5)

FD&C Act 201(g)

21 CFR 310.305

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

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Record Information

Company

MedisourceRx

Inspection Date

June 10, 2025

Product Type

drugs

Office

Office of Compounding Quality and Compliance

People

ID: 1fbda26f-82db-460c-9e19-19e6a0a63187

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