FDA Inspection
Revian Inc.Revian Inc. – FDA Inspection, Mar 22, 2024
Record Details
This FDA Inspection record concerns Revian Inc., with an inspection on March 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c6f661d5-0e56-43ad-b60b-45fdacf7e6a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233779
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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