FDA Inspection
Apotex, Inc.Apotex, Inc. – FDA Inspection, Dec 19, 2008
Record Details
This FDA Inspection record concerns Apotex, Inc., with an inspection on December 19, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Apotex, Inc.
- Inspection Date
- December 19, 2008
- Product Type
- Drugs
View Company Profile
ID · 8377a1ed-7ef2-4ec0-8795-5ea9fd958f48
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 554921
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
Other FDA inspections of Apotex, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 23, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apotex, Inc.
- FDA Inspection 1249246 - 2024-09-27
- FDA Inspection 1230073 - 2024-02-23
- FDA Inspection 1114893 - 2019-11-08
- FDA Inspection 1100432 - 2019-07-12
- FDA Inspection 1035875 - 2017-12-08
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