Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-12.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Apr 2024 – 12 Apr 2024 | Biologics | 483 | View 483 → |
| 25 Jun 2019 – 28 Jun 2019 | Biologics | 483 | View 483 → |
| 6 Jul 2017 – 13 Jul 2017 | Biologics | 483 | View 483 → |
| 12 Mar 2015 | Biologics | Clean | |
| 13 Sep 2012 | Not recorded | 483 | View 483 → |
| 24 Jan 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Apr 2024
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Barbara T Carmichael
12 Apr 2024
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Barbara T Carmichael
12 Apr 2024
21 CFR 1271.55(b)(2)
Listing and interpretation of CD tests performed
Cited by Barbara T Carmichael
12 Apr 2024
21 CFR 1271.65(b)(2)
Labeled re: biohazard, risks, test results
Cited by Barbara T Carmichael
Investigators
FDA investigators tied to this site in the record.
Valerie J Grecek-Trinh2 insp.
Valerie J Grecek Trinh2 insp.
Barbara T Carmichael1 insp.
Julie D Bringger1 insp.
Valerie J Grecek -Trinh1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.75(a)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.65(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind North Florida Reproductive Biology Laboratory's 4 Form 483s
Source PDFs, 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