FDA Inspection
Patheon Italia S.p.A.Patheon Italia S.p.A. – FDA Inspection, Jun 11, 2013
Record Details
This FDA Inspection record concerns Patheon Italia S.p.A., with an inspection on June 11, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Patheon Italia S.p.A.
- Inspection Date
- June 11, 2013
- Product Type
- Drugs
View Company Profile
ID · 7ec4e1eb-ad1f-4245-aaa9-9d7c47dd91cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 839378
- 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 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Patheon Italia S.p.A.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2026 | Not classified | Office of Inspections and Investigations | Vaccines and Allergenic Products |
| September 29, 2023 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 5, 2023 | Not classified | Office of Inspections and Investigations | |
| May 26, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Patheon Italia S.p.A.
- FDA Inspection 1304236 - 2026-02-10
- FDA Inspection 1220064 - 2023-09-29
- FDA Inspection 1223465 - 2023-09-05
- FDA Inspection 1206297 - 2023-05-26
- FDA Inspection 1238005 - 2023-01-26
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