FDA WARNING_LETTER - Genesis Health International Inc. dba Genesis - December 31, 2025

FDA WARNING_LETTER for Genesis Health International Inc. dba Genesis on December 31, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Genesis Health International Inc. dba Genesis on December 31, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 321(p)

21 U.S.C. 331(c)

FD&C Act 503A

FD&C Act 201(g)

21 CFR 201.61(a)

FD&C Act 503B(A)(10)(A)(i)

FD&C Act 301(c)

21 U.S.C. 352(a)

FD&C Act 503(b)

FD&C Act 201(p)

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Record Information

Company

Genesis Health International Inc. dba Genesis

Inspection Date

December 31, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

Matthew J. Lash (Acting Director)

ID: 4a6b3412-54f9-408e-bb1f-e19bc98ac3ff

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