FDA Inspection
Apotex, Inc.Apotex, Inc. – FDA Inspection, Jul 12, 2019
Record Details
This FDA Inspection record concerns Apotex, Inc., with an inspection on July 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8f560e23-4ace-4769-92c5-5cf425bcfb61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100432
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
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 |
| December 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 27, 2016 | 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 1035875 - 2017-12-08
- FDA Inspection 982370 - 2016-05-27
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