FDA Inspection
Catalent Ontario LimitedCatalent Ontario Limited – FDA Inspection, Apr 12, 2019
Record Details
This FDA Inspection record concerns Catalent Ontario Limited, with an inspection on April 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4340e2b7-7e9a-4f00-8d07-299aa461adaf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090476
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Catalent Ontario Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2025 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| November 7, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Catalent Ontario Limited
- FDA Inspection 1268776 - 2025-05-02
- FDA Inspection 906166 - 2014-11-07
- FDA Inspection 748370 - 2011-09-21
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