FDA Inspection
Patheon Italia S.p.APatheon Italia S.p.A – FDA Inspection, Jun 21, 2013
Record Details
This FDA Inspection record concerns Patheon Italia S.p.A, with an inspection on June 21, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Patheon Italia S.p.A
- Inspection Date
- June 21, 2013
- Product Type
- Drugs
View Company Profile
ID · c30229c5-2d91-4d69-97d2-14ecba3ba01f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841054
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.122(d)Labels and labeling stored separately
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Patheon Italia S.p.A
13| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2026 | Not classified | Office of Inspections and Investigations | |
| February 18, 2025 | Not classified | Office of Inspections and Investigations | |
| June 14, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2018 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
Other documents for Patheon Italia S.p.A
- FDA Inspection 1306942 - 2026-01-30
- FDA Inspection 1269289 - 2025-02-18
- FDA Inspection 1174972 - 2022-06-14
- FDA Inspection 1247104 - 2022-02-25
- FDA Inspection 1066263 - 2018-09-21
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