FDA Inspection
Patheon Italia S.p.A.Patheon Italia S.p.A. – FDA Inspection, Sep 29, 2023
Record Details
This FDA Inspection record concerns Patheon Italia S.p.A., with an inspection on September 29, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f5f28954-b749-494d-bde5-fd872496efa9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220064
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.142Written warehousing procedures established/followed
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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 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 |
| April 8, 2022 | 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 1223465 - 2023-09-05
- FDA Inspection 1206297 - 2023-05-26
- FDA Inspection 1238005 - 2023-01-26
- FDA Inspection 1206091 - 2022-04-08
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