Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-09.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Mar 2025 – 9 Apr 2025 | Biologics | 483 | View 483 → |
| 10 Jul 2023 – 25 Jul 2023 | Biologics | 483 | View 483 → |
| 4 Feb 2020 – 13 Feb 2020 | Biologics | Clean | |
| 7 Jun 2018 – 25 Jun 2018 | Biologics | 483 | On file |
| 9 Mar 2016 – 11 Mar 2016 | Biologics | Clean | |
| 3 Dec 2013 – 4 Dec 2013 | Biologics | Clean | |
| 13 Sep 2012 | Not recorded | Clean | |
| 19 Aug 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
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 | 7x |
| 21 CFR 1271.55(d)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kofinas Fertility Group'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