Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-01.
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 |
|---|---|---|---|
| 31 Oct 2023 – 1 Nov 2023 | Biologics | 483 | View 483 → |
| 3 Dec 2019 – 5 Dec 2019 | Biologics | 483 | View 483 → |
| 24 Jul 2018 – 6 Aug 2018 | Biologics | 483 | View 483 → |
| 3 May 2016 | Biologics | 483 | View 483 → |
| 20 Mar 2013 – 21 Mar 2013 | Biologics | Clean | |
| 21 May 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Dec 2019
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Samantha J Pinizzotto
5 Dec 2019
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Samantha J Pinizzotto
5 Dec 2019
21 CFR 1271.65(b)(2)
Labeled re: biohazard, risks, test results
Cited by Samantha J Pinizzotto
Investigators
FDA investigators tied to this site in the record.
Ivan E Reyes2 insp.
Samantha J Pinizzotto1 insp.
Colleen M Aspinwall1 insp.
Barbara T Carmichael1 insp.
Ethan P Stegman1 insp.
Albertfiel A Salvador1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1271.55(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.65(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boca Fertility'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