FDA Inspection
Stephen Cook MDStephen Cook MD – FDA Inspection, Dec 15, 2017
Record Details
This FDA Inspection record concerns Stephen Cook MD, with an inspection on December 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d5014421-a0f4-4b80-9cfe-3a516e356667
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035236
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(3)Investigator's subject records inadequate
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