FDA Inspection
Ann E Woolfrey MDAnn E Woolfrey MD – FDA Inspection, Mar 15, 2010
Record Details
This FDA Inspection record concerns Ann E Woolfrey MD, with an inspection on March 15, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Ann E Woolfrey MD
- Inspection Date
- March 15, 2010
- Product Type
- Biologics
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ID · b876d2e5-b137-4d93-9666-c42bf659f483
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652486
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.110(c)Investigator did not supervise use of investigational device
- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.43(c)No investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
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