Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-09.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Mar 2023 – 9 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Mar 2016 – 17 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2014 – 5 Feb 2014 | Medical Devices & Rad Health | Clean | |
| 7 Dec 2012 | Not recorded | 483 | On file |
| 23 Sep 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Mar 2016
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Bonnie E Conley, Ashley N Jeans, Bonnie E Pierson, Ashley N Brooks
Investigators
FDA investigators tied to this site in the record.
Whitney White2 insp.
Nikki S Bryant1 insp.
Bonnie E Conley1 insp.
Ashley N Jeans1 insp.
Bonnie E Pierson1 insp.
Ashley N Brooks1 insp.
Donna D Gallien1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | 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 CryoSurgery, Inc.'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