FDA Inspection
Vacutest Kima SRLVacutest Kima SRL – FDA Inspection, Dec 13, 2019
Record Details
This FDA Inspection record concerns Vacutest Kima SRL, with an inspection on December 13, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vacutest Kima SRL
- Inspection Date
- December 13, 2019
- Product Type
- Devices
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ID · c70693ad-442b-4bf8-84ee-1b74aa450806
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115254
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.70(i)Software validation for automated processes
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