FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, Mar 18, 2024
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on March 18, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 93f1415d-810f-457a-b070-74acb3e5fdba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230688
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.113(b)Procedures for sterile drug products
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 | |
| June 13, 2024 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| 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 1230469 - 2024-06-13
- FDA Inspection 1076243 - 2018-12-17
- FDA Inspection 1039401 - 2017-12-07
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