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FDA Inspection
•Apotex Inc.•August 14, 2009

Apotex Inc. – FDA Inspection, Aug 14, 2009

Record Details

This FDA Inspection record concerns Apotex Inc., with an inspection on August 14, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Apotex Inc.
Inspection Date
August 14, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 07fb7a34-7524-466b-96ba-43814f51fb96

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
610738
FDA center
Human Drugs
Project area
Drug Quality Assurance

Other FDA inspections of Apotex Inc.

10
DateClassificationOfficeProject area
September 25, 2026Not classifiedOffice of Inspections and Investigations
July 31, 2025Not classifiedOffice of Inspections and Investigations
September 23, 2022NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 19, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 10, 2018NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
View all 10 other inspections on the company page
Other documents for Apotex Inc.
  • FDA Inspection 1340300 - 2026-09-25
  • FDA Inspection 1269753 - 2025-07-31
  • FDA Inspection 1187415 - 2022-09-23
  • FDA Inspection 1096465 - 2019-06-19
  • FDA Inspection 1055197 - 2018-05-10

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