Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-07-25.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jul 2019 – 25 Jul 2019 | Biologics | 483 | View 483 → |
| 17 Jan 2017 – 18 Jan 2017 | Biologics | Clean | |
| 24 Feb 2015 – 27 Feb 2015 | Biologics | Clean | |
| 9 May 2013 – 10 May 2013 | Biologics | Clean | |
| 21 Jul 2010 | Not recorded | 483 | On file |
| 28 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2019
21 CFR 1271.85(a)
Infection with communicable disease agents
Cited by Amy A Johnson, Kenneth L Smalls
25 Jul 2019
21 CFR 1271.85(a)
Infection with communicable disease agents
Cited by Amy A Johnson, Kenneth L Smalls
Investigators
FDA investigators tied to this site in the record.
Kenneth L Smalls3 insp.
Amy A Johnson2 insp.
Richard J Bashay1 insp.
Amy C Amaro1 insp.
Sherry L Secrist1 insp.
Andria L Kuhlman1 insp.
Wilfred A Darang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind The Cryo Laboratory of EVMS Medical Group's 2 Form 483s
Source PDFs 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