Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-28.
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 |
|---|---|---|---|
| 26 Feb 2025 – 28 Feb 2025 | Biologics | Clean | |
| 20 Jun 2023 – 22 Jun 2023 | Biologics | Clean | |
| 9 Feb 2022 – 8 Mar 2022 | Biologics | 483 | View 483 → |
| 9 Feb 2022 – 18 Feb 2022 | Biologics | Clean | |
| 2 Apr 2019 – 3 Apr 2019 | Biologics | Clean | |
| 13 Mar 2017 – 14 Mar 2017 | Biologics | Clean | |
| 14 Jul 2015 – 15 Jul 2015 | Biologics | 483 | View 483 → |
| 30 Oct 2013 – 7 Nov 2013 | Biologics | 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.
Mizanne E Lewis3 insp.
Lura D Baquero3 insp.
Barbara T Carmichael1 insp.
Lura D Kelly1 insp.
Stacey F Rivette1 insp.
Leena Thomas1 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(e) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.85(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cryos International USA, 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