FDA Inspection
DOMINO S.R.L.DOMINO S.R.L. – FDA Inspection, Jun 5, 2014
Record Details
This FDA Inspection record concerns DOMINO S.R.L., with an inspection on June 5, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DOMINO S.R.L.
- Inspection Date
- June 5, 2014
- Product Type
- Devices
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ID · 356aa289-6296-407d-a1ce-f3f071d026f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 887570
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of DOMINO S.R.L.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2024 | Not classified | Office of Inspections and Investigations | |
| September 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DOMINO S.R.L.
- FDA Inspection 1259259 - 2024-12-19
- FDA Inspection 1027961 - 2017-09-14
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