FDA Inspection
Apotex Pharmachem Inc.Apotex Pharmachem Inc. – FDA Inspection, Dec 2, 2016
Record Details
This FDA Inspection record concerns Apotex Pharmachem Inc., with an inspection on December 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Yumi J. Hiramine (Issuing Officer)
View Company Profile
ID · 1ce481f9-9281-4de9-bc23-7280dedb9e02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002803
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Apotex Pharmachem Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2025 | Not classified | Office of Inspections and Investigations | |
| December 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 24, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apotex Pharmachem Inc.
- FDA Inspection 1269863 - 2025-05-09
- FDA Inspection 1194792 - 2022-12-16
- FDA Inspection 1095165 - 2019-05-24
- FDA Inspection 905258 - 2014-11-21
- FDA Inspection 769352 - 2012-02-03
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