FDA Inspection
Patheon Pharmaceuticals Inc.Patheon Pharmaceuticals Inc. – FDA Inspection, Sep 26, 2025
Record Details
This FDA Inspection record concerns Patheon Pharmaceuticals Inc., with an inspection on September 26, 2025, issued by the Cincinnati District Office, covering human drugs.
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ID · ee9dd4e9-579e-445b-8896-014b387bbc11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1281564
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Patheon Pharmaceuticals Inc.
16| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon Pharmaceuticals Inc.
- FDA Inspection 1211249 - 2023-07-24
- FDA Inspection 1204466 - 2023-04-21
- FDA Inspection 1117783 - 2020-01-14
- FDA Inspection 1079809 - 2019-02-15
- FDA Inspection 1040994 - 2018-02-14
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