FDA Inspection
Kennedy, Philip R.Kennedy, Philip R. – FDA Inspection, Oct 16, 2019
Record Details
This FDA Inspection record concerns Kennedy, Philip R., with an inspection on October 16, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kennedy, Philip R.
- Inspection Date
- October 16, 2019
- Product Type
- Devices
View Company Profile
ID · b9ae7d0e-8339-430e-93a7-a4e0489845dc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1106571
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Enforcement
- Warning Letter
FDA Citations
9- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.150(b)(6)Sponsor notif. of rqst. to return/repair/dispose not made
- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.150(b)(1)Sponsor evaluation rpt not timely, distributed
- 21 CFR 812.140(d)Record retention inadequate
- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kennedy, Philip R.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2009 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Kennedy, Philip R.
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.