FDA Inspection
John G. Costouros, M.D.John G. Costouros, M.D. – FDA Inspection, Apr 6, 2016
Record Details
This FDA Inspection record concerns John G. Costouros, M.D., with an inspection on April 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- John G. Costouros, M.D.
- Inspection Date
- April 6, 2016
- Product Type
- Devices
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ID · 67834f4e-988e-42f5-9738-68a7b9479bf8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967513
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
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