Apitoria Pharma Private LimitedOctober 28, 2019

FDA 483 - Apitoria Pharma Private Limited - October 28, 2019

FDA 483 for Apitoria Pharma Private Limited on October 28, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA 483 for Apitoria Pharma Private Limited on October 28, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

FD&C Act 801(a)(3)

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

21 CFR 211.58

21 CFR 211.194(a)

21 CFR 211.166(a)

21 CFR 211.22(d)

21 CFR 211.165(e)

21 CFR 211.67(a)

21 CFR 211.42(c)

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Record Information

Company

Apitoria Pharma Private Limited

Inspection Date

October 28, 2019

Product Type

Drugs

Office

Office of Regulatory Affairs

People

Michael A. Charles (Investigator)

ID: 256c0014-cf42-4df3-a59e-37e9d4777227

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