FDA Inspection
Micromed S.p.A.Micromed S.p.A. – FDA Inspection, Aug 29, 2018
Record Details
This FDA Inspection record concerns Micromed S.p.A., with an inspection on August 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shaquenta Y. Perkins (Issuing Officer)
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ID · 5e4fd503-9431-4fc0-a66d-4728455ae8c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065344
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Micromed S.p.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Micromed S.p.A.
- FDA Inspection 915525 - 2015-02-11
- FDA Inspection 804734 - 2012-09-19
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