FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, Aug 4, 2022
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on August 4, 2022, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 4, 2022
- Product Type
- Biologics
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ID · 47f4705a-9811-44c2-9b0a-dc05404ad9e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1176425
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
4- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
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 |
| May 17, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 1096860 - 2019-05-17
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