FDA Inspection
Herman A. Jenkins, MDHerman A. Jenkins, MD – FDA Inspection, May 25, 2010
Record Details
This FDA Inspection record concerns Herman A. Jenkins, MD, with an inspection on May 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Herman A. Jenkins, MD
- Inspection Date
- May 25, 2010
- Product Type
- Devices
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ID · 427a18aa-4ad1-4813-9059-ecf550ed25fd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 663394
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.150(a)(4)Investigator non-emergency safety or soundness changes
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records 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)(2)(i)Investigator device accountability inadequate
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Other FDA inspections of Herman A. Jenkins, MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Herman A. Jenkins, MD
- FDA Inspection 764020 - 2012-01-19
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