FDA Inspection
Delta Med SpADelta Med SpA – FDA Inspection, Oct 26, 2017
Record Details
This FDA Inspection record concerns Delta Med SpA, with an inspection on October 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ecffd11a-5eb7-4261-8c2e-28c01ea534c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029762
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Delta Med SpA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2018 | Not classified | Office of Inspections and Investigations | |
| May 3, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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