FDA Inspection
Apotex Fermentation Inc.Apotex Fermentation Inc. – FDA Inspection, Mar 22, 2019
Record Details
This FDA Inspection record concerns Apotex Fermentation Inc., with an inspection on March 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6f68e5e8-4799-4ee7-a422-fb19d5eb126f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083696
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Apotex Fermentation Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 7, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apotex Fermentation Inc.
- FDA Inspection 905899 - 2014-10-31
- FDA Inspection 787176 - 2012-06-07
- FDA Inspection 666011 - 2010-03-12
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