FDA Inspection
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA Inspection, Dec 21, 2010
Record Details
This FDA Inspection record concerns Patheon Manufacturing Services LLC, with an inspection on December 21, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 21, 2010
- Product Type
- Drugs
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ID · 13443903-dc38-439b-9fa8-107749439a07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697759
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.186(b)(3)Components complete listing
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 17, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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