FDA Inspection
John MeadorsJohn Meadors – FDA Inspection, May 7, 2018
Record Details
This FDA Inspection record concerns John Meadors, with an inspection on May 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ba99ab08-8312-41c2-a5d0-75d35f296508
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1050997
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(e)Notice of transfer of responsibility for records
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(3)(iii)Investigator records of exposure to device inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.110(a)Subject participation prior to study approval
- 21 CFR 812.140(a)(3)Investigator's subject records inadequate
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