FDA Inspection
Patheon Pharmaceuticals Inc.Patheon Pharmaceuticals Inc. – FDA Inspection, Mar 2, 2017
Record Details
This FDA Inspection record concerns Patheon Pharmaceuticals Inc., with an inspection on March 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 401d460c-0b1b-4e07-a8b9-43701e72162b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003802
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Patheon Pharmaceuticals Inc.
16| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | VAI | Cincinnati District Office | Drug Quality Assurance |
| July 24, 2023 | Not classified | Cincinnati District Office | |
| April 21, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 14, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2019 | OAI | Cincinnati District Office | Generic Drug Evaluation |
Other documents for Patheon Pharmaceuticals Inc.
- FDA Inspection 1281564 - 2025-09-26
- FDA Inspection 1211249 - 2023-07-24
- FDA Inspection 1204466 - 2023-04-21
- FDA Inspection 1117783 - 2020-01-14
- FDA Inspection 1079809 - 2019-02-15
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