FDA Inspection
DIMA ITALIA SRLDIMA ITALIA SRL – FDA Inspection, Jul 26, 2012
Record Details
This FDA Inspection record concerns DIMA ITALIA SRL, with an inspection on July 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DIMA ITALIA SRL
- Inspection Date
- July 26, 2012
- Product Type
- Devices
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ID · cc555d40-74f5-4aa0-bc85-ce7e9e0472e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794734
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
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