FDA WARNING_LETTER - Apothecus Pharmaceutical Corp. - April 30, 2019

FDA WARNING_LETTER for Apothecus Pharmaceutical Corp. on April 30, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Apothecus Pharmaceutical Corp. on April 30, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 4

21 CFR 211

21 U.S.C. 353(g)

21 CFR 211.68(b)

21 CFR 210

21 CFR 211.22(a)

21 CFR 211.192

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Record Information

Company

Apothecus Pharmaceutical Corp.

Inspection Date

April 30, 2019

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Diana Amador-Toro (District Director)

ID: f58b01f8-f932-4fcf-9793-d9612d62a769

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