FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, Dec 17, 2018
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on December 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Frank J. Marciniak (Issuing Officer)
- Melissa A. Zuppe
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ID · a16c3dd8-72d1-454b-9cca-526fb4bbd36a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076243
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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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 |
| March 18, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1230688 - 2024-03-18
- FDA Inspection 1039401 - 2017-12-07
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