FDA Inspection
Apotex Inc.Apotex Inc. – FDA Inspection, Jun 14, 2017
Record Details
This FDA Inspection record concerns Apotex Inc., with an inspection on June 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cdb79898-0a6b-44c3-803f-1591c1dab0be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014399
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.68(b)Backup file not maintained
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Other FDA inspections of Apotex Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2026 | Not classified | Office of Inspections and Investigations | |
| July 31, 2025 | Not classified | Office of Inspections and Investigations | |
| September 23, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 19, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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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