FDA Inspection
New England Baptist Hospital IRB #1New England Baptist Hospital IRB #1 – FDA Inspection, May 26, 2009
Record Details
This FDA Inspection record concerns New England Baptist Hospital IRB #1, with an inspection on May 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 26, 2009
- Product Type
- Devices
View Company Profile
ID · 97692157-9b86-4d6d-a8d5-a4766873b492
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 592368
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New England Baptist Hospital IRB #1
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2019 | NAI | Bioresearch Monitoring | |
| February 12, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for New England Baptist Hospital IRB #1
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.