FDA WARNING_LETTER - Patheon Manufacturing Services LLC - January 25, 2022

FDA WARNING_LETTER for Patheon Manufacturing Services LLC on January 25, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Patheon Manufacturing Services LLC on January 25, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(a)

21 U.S.C. 321(g)(1)(B)

21 CFR 201.128

21 U.S.C. 321(g)(1)(C)

21 U.S.C. 352(i)

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Record Information

Company

Patheon Manufacturing Services LLC

Inspection Date

January 25, 2022

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Carolyn E. Becker

ID: a31b625f-da20-431d-bdca-d1753a931b89

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