FDA WARNING_LETTER - Bi-Coastal Pharma International - January 14, 2022

FDA WARNING_LETTER for Bi-Coastal Pharma International on January 14, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Bi-Coastal Pharma International on January 14, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 211

21 CFR 211.198(a)

21 CFR 210

21 CFR 211.22(a)

21 CFR 211.25(b)

21 CFR 211.192

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

21 CFR 211.22(d)

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Record Information

Company

Bi-Coastal Pharma International

Inspection Date

January 14, 2022

Product Type

Drugs

Office

Office of Pharmaceutical Quality Operations Division I

People

Nerizza Guerin (Director of Investigations Branch)

ID: 9d69b93a-a4bd-41ab-bcb4-264b50e2661a

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