FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, Dec 17, 2015
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on December 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 17, 2015
- Product Type
- Drugs
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ID · dbe34fd0-2ea3-4116-98b8-72d3dd7cfe6e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985597
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(a)Following/documenting laboratory controls
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Other FDA inspections of Patheon Manufacturing Services LLC
17| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | NAI | Atlanta District Office | Drug Quality Assurance |
| November 27, 2024 | Not classified | Atlanta District Office | |
| May 24, 2024 | Not classified | Atlanta District Office | Drug Quality Assurance |
| February 23, 2024 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 4, 2022 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for Patheon Manufacturing Services LLC
- FDA Inspection 1270187 - 2025-09-26
- FDA Inspection 1257333 - 2024-11-27
- FDA Inspection 1238532 - 2024-05-24
- FDA Inspection 1229060 - 2024-02-23
- FDA Inspection 1176425 - 2022-08-04
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