Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-03-17.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2023 – 17 Mar 2023 | Medical Devices & Rad Health | Clean | |
| 14 Aug 2018 – 22 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Jan 2015 – 15 Jan 2015 | Medical Devices & Rad Health | Clean | |
| 19 Sep 2012 | Not recorded | Clean | |
| 4 Oct 2010 | Not recorded | Clean | |
| 2 Feb 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Aug 2018
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Sargum C Sood
Investigators
FDA investigators tied to this site in the record.
David J Gasparovich1 insp.
Sargum C Sood1 insp.
Erin M Miller1 insp.
Theodore N Sietsema1 insp.
Bleta Vuniqi1 insp.
Martha Sullivan Myrick1 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 | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Medisurge, LLC.'s 1 Form 483
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