FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, Jun 21, 2011
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on June 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 21, 2011
- Product Type
- Drugs
View Company Profile
ID · 0a5e7e55-d98e-447d-a9de-6749ea565092
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 731289
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.110(a)Written in-process control procedures
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 |
| 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 |
Other documents for Patheon Manufacturing Services LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.