Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-25.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Sep 2024 – 25 Sep 2024 | Biologics | Clean | |
| 26 Sep 2022 – 27 Sep 2022 | Biologics | Clean | |
| 8 Jul 2021 – 14 Jul 2021 | Biologics | 483 | View 483 → |
| 9 Dec 2019 – 11 Dec 2019 | Biologics | 483 | View 483 → |
| 11 Oct 2017 – 12 Oct 2017 | Biologics | 483 | View 483 → |
| 7 Jan 2016 | Biologics | Clean | |
| 17 Jun 2013 | Biologics | Clean | |
| 5 Jan 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jul 2021
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Lura D Baquero, Douglas Fiorentino
14 Jul 2021
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Lura D Baquero, Douglas Fiorentino
14 Jul 2021
21 CFR 1271.55(b)(2)
Listing and interpretation of CD tests performed
Cited by Lura D Baquero, Douglas Fiorentino
14 Jul 2021
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Lura D Baquero, Douglas Fiorentino
Investigators
FDA investigators tied to this site in the record.
Lura D Baquero4 insp.
Mizanne E Lewis2 insp.
Stacey F Rivette2 insp.
Lura D Kelly1 insp.
Douglas Fiorentino1 insp.
Holly M Scott1 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 1271.47(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.55(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind IVF Laboratory of Central Florida LLC's 3 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