FDA Inspection
Catalent Ontario LimitedCatalent Ontario Limited – FDA Inspection, May 2, 2025
Record Details
This FDA Inspection record concerns Catalent Ontario Limited, with an inspection on May 2, 2025, issued by the Office of Inspections and Investigations, covering animal drugs & feeds.
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ID · 87a9e5f6-53a1-449b-a2bd-f7757461366e
Inspection Facts
- Inspection number
- 1268776
- FDA center
- Animal Drugs & Feeds
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Catalent Ontario Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2019 | VAI | Center for Drug Evaluation and Research | 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 1090476 - 2019-04-12
- FDA Inspection 906166 - 2014-11-07
- FDA Inspection 748370 - 2011-09-21
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