FDA Inspection
JFK Health IRBJFK Health IRB – FDA Inspection, Feb 19, 2016
Record Details
This FDA Inspection record concerns JFK Health IRB, with an inspection on February 19, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- JFK Health IRB
- Inspection Date
- February 19, 2016
- Product Type
- Drugs
View Company Profile
ID · 0eeaa10e-d813-4e03-a5f0-d0a6733c74ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 959710
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.109(b)Information given to subjects
Full citation text and observation details available on the Dashboard.
Other FDA inspections of JFK Health IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for JFK Health IRB
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.