FDA Inspection
Aziende Chimiche Riunite Angelini Francesco S.p.A.Aziende Chimiche Riunite Angelini Francesco S.p.A. – FDA Inspection, Jan 26, 2012
Record Details
This FDA Inspection record concerns Aziende Chimiche Riunite Angelini Francesco S.p.A., with an inspection on January 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 26, 2012
- Product Type
- Devices
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ID · 87acdbd2-0c89-4395-a506-335a89df4ec9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 768222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document locations, Dissemination, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Aziende Chimiche Riunite Angelini Francesco S.p.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2025 | Not classified | Office of Inspections and Investigations | |
| December 15, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aziende Chimiche Riunite Angelini Francesco S.p.A.
- FDA Inspection 1272432 - 2025-05-14
- FDA Inspection 1195288 - 2022-12-15
- FDA Inspection 939495 - 2015-08-06
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