FDA Inspection
Emma J. Patterson, M.D.Emma J. Patterson, M.D. – FDA Inspection, Jul 15, 2011
Record Details
This FDA Inspection record concerns Emma J. Patterson, M.D., with an inspection on July 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Emma J. Patterson, M.D.
- Inspection Date
- July 15, 2011
- Product Type
- Devices
View Company Profile
ID · 78be9667-9e12-4656-9b63-53f2c96c497b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734526
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 50.55(f)Documentation of permission by parents or guardian
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.