Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-06-14.
At a glance
Inspections
9
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 May 2022 – 14 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Aug 2021 – 17 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 May 2018 – 14 Jun 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Dec 2016 – 20 Dec 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Aug 2015 – 22 Oct 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Oct 2014 – 29 Oct 2014 | Medical Devices & Rad Health | WL | View 483 → |
| 19 Aug 2013 – 26 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 May 2011 | Not recorded | Clean | |
| 11 Apr 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jun 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Eric C Schmitt, Angel A Soler-Garcia
14 Jun 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Eric C Schmitt, Angel A Soler-Garcia
14 Jun 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Eric C Schmitt, Angel A Soler-Garcia
14 Jun 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Eric C Schmitt, Angel A Soler-Garcia
17 Sep 2021
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Jeffrey J Thibodeau
Investigators
FDA investigators tied to this site in the record.
Jeffrey J Thibodeau3 insp.
Eric C Schmitt1 insp.
Angel A Soler-Garcia1 insp.
Stephen C Smith1 insp.
Tamara S Rosbury1 insp.
Camerson E Moore1 insp.
Jonathan B Lewis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Karl Storz Endovision, Inc.'s 7 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