FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, May 19, 2026
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on May 19, 2026, issued by the New Jersey District Office, covering biologics.
- People
- Laurel A. Beer (Issuing Officer)
- Shafiq Ahadi (Issuing Officer)
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ID · 21ed12f9-9d1a-421d-a19b-9a6f78a01bab
Inspection Facts
- Inspection number
- 1317726
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(b)Backup file not maintained
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Other FDA inspections of Patheon Manufacturing Services LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2024 | Not classified | New Jersey District Office | |
| June 13, 2024 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| 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 1271322 - 2024-08-30
- FDA Inspection 1230469 - 2024-06-13
- FDA Inspection 1230688 - 2024-03-18
- FDA Inspection 1076243 - 2018-12-17
- FDA Inspection 1039401 - 2017-12-07
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