FDA Inspection
Scully, Sean P.FDA Inspection 654411 - Scully, Sean P. - April 15, 2010
Record Details
This FDA Inspection record concerns Scully, Sean P., with an inspection on April 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Scully, Sean P.
- Inspection Date
- April 15, 2010
- Product Type
- Devices
View Company Profile
ID · 12640d57-f1e6-43c9-ad9a-fcbef96328e3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 654411
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(4)Investigator protocol records inadequate
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.150(a)(3)No investigator progress reports
- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.110(d)Inadequate financial disclosure by investigator
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.