FDA WARNING_LETTER - Lumimeds - August 31, 2025

FDA WARNING_LETTER for Lumimeds on August 31, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Lumimeds on August 31, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(c)

FD&C Act 301(c)

21 U.S.C. 352(a)

21 U.S.C. 352(bb)

21.U.S.C. 331(a)

FD&C Act 301(a)

FD&C Act 502(b)

FD&C Act 502(a)

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Record Information

Company

Lumimeds

Inspection Date

August 31, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

George Tidmarsh (Director)

ID: efc1c569-0e81-4c29-9869-e9283a6c8929

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