FDA Inspection
Bayfront Medical Center- IRBBayfront Medical Center- IRB – FDA Inspection, Aug 9, 2011
Record Details
This FDA Inspection record concerns Bayfront Medical Center- IRB, with an inspection on August 9, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bayfront Medical Center- IRB
- Inspection Date
- August 9, 2011
- Product Type
- Drugs
View Company Profile
ID · 6877131f-8432-4063-b782-41f31d11629a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 739836
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bayfront Medical Center- IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 29, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Bayfront Medical Center- IRB
- FDA Inspection 878305 - 2014-03-26
- FDA Inspection 618305 - 2009-09-29
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.