Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-06.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Oct 2022 – 6 Oct 2022 | Medical Devices & Rad Health | Clean | |
| 7 Oct 2015 – 14 Oct 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jun 2013 – 9 Jul 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jan 2013 | Not recorded | 483 | View 483 → |
| 9 Feb 2011 | Not recorded | Clean | |
| 30 Sep 2009 | Not recorded | WL | View 483 → |
| 12 Mar 2008 | Not recorded | 483 | On file |
| 7 Aug 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jul 2013
21 CFR 820.70(b)
Production and Process Change Procedures, lack of or Inad.
Cited by Stephen R Souza, Cynthia L Gorveatt
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza2 insp.
Cynthia L Gorveatt2 insp.
Christopher S Genther1 insp.
Paul M Kawamoto1 insp.
Lori J Silverstein1 insp.
Deborah A Nebenzahl1 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 | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EndoGastric Solutions, Inc.'s 5 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