Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-07.
At a glance
Inspections
7
Form 483s
2
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 May 2024 – 7 Jun 2024 | Biologics | 483 | View 483 → |
| 22 Jul 2022 – 25 Jul 2022 | Biologics | Clean | |
| 2 Jul 2019 – 9 Jul 2019 | Biologics | Clean | |
| 9 Jan 2017 – 12 Jan 2017 | Biologics | Clean | |
| 9 Sep 2015 – 14 Sep 2015 | Biologics | Clean | |
| 3 Apr 2013 – 12 Apr 2013 | Biologics | 483 | View 483 → |
| 13 Jan 2010 | 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.
Irina Gaberman3 insp.
Amy W Yan Mai1 insp.
Amy W Yan-Mai1 insp.
Amy Kim1 insp.
Kellie Leveille1 insp.
Evelyn Taha1 insp.
Matthew R Palo1 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 | 1x |
| 21 CFR 1271.55(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(e) | 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 California Cryobank LLC d.b.a. Cooper Surgical's 2 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