FDA Inspection 1269710 - Apotex Inc. - May 09, 2025

FDA Inspection 1269710 for Apotex Inc. on May 09, 2025. Classification: OAI.

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Record Summary

FDA Inspection 1269710 for Apotex Inc. on May 09, 2025. Classification: OAI.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.110(a)

21 CFR 211.113(b)

21 CFR 211.160(a)

21 CFR 211.192

21 CFR 211.198(a)

21 CFR 211.42(c)(10)(vi)

21 CFR 211.67(a)

21 CFR 211.68(b)

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Record Information

Company

Apotex Inc.

Inspection Date

May 9, 2025

Product Type

Human Drugs

Office

Office of Inspections and Investigations

ID: 703c7656-f27a-4908-9f8d-7a38c7b5f345

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