FDA Inspection
Neil R. Feins, M.D.Neil R. Feins, M.D. – FDA Inspection, Feb 17, 2009
Record Details
This FDA Inspection record concerns Neil R. Feins, M.D., with an inspection on February 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Neil R. Feins, M.D.
- Inspection Date
- February 17, 2009
- Product Type
- Devices
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ID · 758293c5-3610-41f6-8136-76a75c1b4f0e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 565701
- 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)(2)(i)Investigator device accountability inadequate
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