FDA Inspection
Patheon Biologics LLCPatheon Biologics LLC – FDA Inspection, Aug 2, 2019
Record Details
This FDA Inspection record concerns Patheon Biologics LLC, with an inspection on August 2, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7f3767c1-109b-46a2-aeee-f4d6bbba602c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099387
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Patheon Biologics LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2024 | Not classified | Kansas City District Office | |
| December 8, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2023 | Not classified | Kansas City District Office | |
| March 2, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 24, 2023 | Not classified | Kansas City District Office |
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