FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, Jun 13, 2024
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on June 13, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · c41b58a3-eb8b-4871-b27c-f718b59a8c85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230469
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
3- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 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
12| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2026 | Not classified | New Jersey District Office | Vaccines and Allergenic Products |
| August 30, 2024 | Not classified | New Jersey District Office | |
| March 18, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 17, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon Manufacturing Services LLC
- FDA Inspection 1317726 - 2026-05-19
- FDA Inspection 1271322 - 2024-08-30
- FDA Inspection 1230688 - 2024-03-18
- FDA Inspection 1076243 - 2018-12-17
- FDA Inspection 1039401 - 2017-12-07
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