FDA Inspection
Bayfront Medical Center- IRBBayfront Medical Center- IRB – FDA Inspection, Sep 29, 2009
Record Details
This FDA Inspection record concerns Bayfront Medical Center- IRB, with an inspection on September 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bayfront Medical Center- IRB
- Inspection Date
- September 29, 2009
- Product Type
- Drugs
View Company Profile
ID · 7a49175a-2fb9-4f95-9d82-7d25ada816f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 618305
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.113Reporting
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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 |
| August 9, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Bayfront Medical Center- IRB
- FDA Inspection 878305 - 2014-03-26
- FDA Inspection 739836 - 2011-08-09
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