FDA WARNING_LETTER - PIL - April 08, 2025

FDA WARNING_LETTER for PIL on April 08, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for PIL on April 08, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 331(a)

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

21 U.S.C. 331(k)

21 U.S.C. 321(g)

21 CFR 201.115(a)

21 U.S.C. 352(f)(1)

21 CFR 201.128

21 U.S.C. 353(b)

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Record Information

Company

PIL

Inspection Date

April 8, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Leigh Verbois (Director)

ID: c5b69b7a-66b3-454d-9c60-87e09e9ba307

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