FDA Inspection
William Balcom, M.D.William Balcom, M.D. – FDA Inspection, Mar 27, 2015
Record Details
This FDA Inspection record concerns William Balcom, M.D., with an inspection on March 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- William Balcom, M.D.
- Inspection Date
- March 27, 2015
- Product Type
- Devices
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ID · 124bfaf2-df91-46bf-8c08-9f031e799c14
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 922247
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
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Other FDA inspections of William Balcom, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for William Balcom, M.D.
- FDA Inspection 1023486 - 2017-07-14
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