FDA Inspection
Brava, LLCBrava, LLC – FDA Inspection, Mar 14, 2014
Record Details
This FDA Inspection record concerns Brava, LLC, with an inspection on March 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brava, LLC
- Inspection Date
- March 14, 2014
- Product Type
- Devices
View Company Profile
ID · b7d5a8dc-19eb-4714-922a-6457fe61ae51
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 870691
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.36(e)No IRB approval for treatment use
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(4)(v)Sponsor records re QSR/GMP & non-significant risk studies
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Brava, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 4, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 9, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Brava, LLC
- FDA Inspection 938041 - 2015-08-10
- FDA Inspection 718242 - 2011-04-04
- FDA Inspection 679945 - 2010-09-09
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.