Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-03-26.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2014 – 26 Mar 2014 | Human Drugs | Clean | |
| 9 Aug 2011 | Not recorded | 483 | View 483 → |
| 29 Sep 2009 | Not recorded | 483 | View 483 → |
| 22 Aug 2006 | Not recorded | Clean | |
| 1 Mar 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Aug 2011
21 CFR 50.25(a)(5)
Confidentiality, FDA inspection of records
Cited by Gene R Gunn, Rodney W Lenger
9 Aug 2011
21 CFR 56.108(a)(2)
More frequent reviews, verification of no changes
Cited by Gene R Gunn, Rodney W Lenger
29 Sep 2009
21 CFR 56.108(a)(1)
Reporting findings and actions to investigator/institution
Cited by Leslie A Cartmill, Joan S Norton
29 Sep 2009
21 CFR 56.108(b)(1)
Prompt reporting of unanticipated problems
Cited by Leslie A Cartmill, Joan S Norton
Investigators
FDA investigators tied to this site in the record.
Bill Tackett1 insp.
Gene R Gunn1 insp.
Rodney W Lenger1 insp.
Leslie A Cartmill1 insp.
Joan S Norton1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 50.25(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.113 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bayfront Medical Center- IRB's 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat