FDA WARNING_LETTER - www.plakini-pharma.com - July 29, 2025

FDA WARNING_LETTER for www.plakini-pharma.com on July 29, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for www.plakini-pharma.com on July 29, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

FD&C Act 301(d)

21 U.S.C. 321(p)

FD&C Act 201(g)

21 U.S.C. 331(a)

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

FD&C Act 201(p)

21 U.S.C. 321(g)

FD&C Act 301(a)

21 CFR 201.115(a)

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Record Information

Company

www.plakini-pharma.com

Inspection Date

July 29, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Sangeeta V. Chatterjee

ID: d659dc86-ed1b-4882-a63d-4f301a546ab1

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