Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-03.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2025 – 3 Mar 2025 | Medical Devices & Rad Health | Clean | |
| 13 Apr 2022 – 20 Apr 2022 | Medical Devices & Rad Health | Clean | |
| 21 Feb 2018 – 27 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 11 Dec 2013 – 19 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 May 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Dec 2013
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Eric J Cunningham
19 Dec 2013
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
Cited by Eric J Cunningham
16 May 2011
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Kristen E Rescigno
Investigators
FDA investigators tied to this site in the record.
David H Smith2 insp.
Jonathan Ho1 insp.
Matthew W Kyle1 insp.
Eric J Cunningham1 insp.
Kristen E Rescigno1 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 | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Viscot Medical LLC'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