FDA Inspection
Patheon Pharmaceuticals Inc.Patheon Pharmaceuticals Inc. – FDA Inspection, Feb 15, 2019
Record Details
This FDA Inspection record concerns Patheon Pharmaceuticals Inc., with an inspection on February 15, 2019, issued by the Cincinnati District Office, covering human drugs.
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ID · b7f1e1d6-1287-4cf0-8ca2-0c82a8009bbb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1079809
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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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 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 1040994 - 2018-02-14
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