FDA WARNING_LETTER - Pfizer Healthcare India Private Limited - September 06, 2019

FDA WARNING_LETTER for Pfizer Healthcare India Private Limited on September 06, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Pfizer Healthcare India Private Limited on September 06, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

FD&C Act 501(a)(2)(B)

21 CFR 211

21 CFR 210

21 CFR 211.192

21 U.S.C. 381(a)(3)

21 U.S.C. 351(a)(2)(B)

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Record Information

Company

Pfizer Healthcare India Private Limited

Inspection Date

September 6, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 5f96070a-9d0d-4a20-a254-22cfb2546131

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