FDA Inspection
Nucryo Vascular Inc.Nucryo Vascular Inc. – FDA Inspection, Sep 12, 2019
Record Details
This FDA Inspection record concerns Nucryo Vascular Inc., with an inspection on September 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bdbc0413-4926-4c3f-b5f5-bda5e06f003d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101852
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 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 - production units
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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