FDA Inspection
Vitalcor, Inc.Vitalcor, Inc. – FDA Inspection, Jan 11, 2017
Record Details
This FDA Inspection record concerns Vitalcor, Inc., with an inspection on January 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8fe98f6a-4db9-4d47-a625-a8fdc10b2279
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005602
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17Lack of Written MDR Procedures
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