FDA Inspection
Patheon Italia S.p.APatheon Italia S.p.A – FDA Inspection, Sep 21, 2018
Record Details
This FDA Inspection record concerns Patheon Italia S.p.A, with an inspection on September 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9424f79f-1064-4e4e-8c77-c1a42846814c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066263
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192No written record of investigation
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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 |
| February 17, 2017 | VAI | Office of Inspections and Investigations | 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 1008164 - 2017-02-17
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