Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-23.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2025 – 23 Jan 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Aug 2021 – 19 Aug 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Sep 2018 – 21 Sep 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 May 2014 – 8 May 2014 | Medical Devices & Rad Health | Clean | |
| 31 Jan 2008 | Not recorded | 483 | On file |
| 13 Apr 2006 | Not recorded | Clean | |
| 22 Dec 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Juanj Wu1 insp.
Angelica G Aziz1 insp.
Dianiris C Ayala1 insp.
Charles L Larson1 insp.
Yvette E Guillermo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Vitrolife Inc.'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