Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-15.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Feb 2024 – 15 Feb 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Apr 2022 – 24 May 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 May 2019 – 4 Jun 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jan 2017 – 10 Jan 2017 | Medical Devices & Rad Health | Clean | |
| 5 Jan 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 May 2022
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Jeffrey J Thibodeau, Joann F Fujikawa
24 May 2022
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Jeffrey J Thibodeau, Joann F Fujikawa
Investigators
FDA investigators tied to this site in the record.
Jeffrey J Thibodeau2 insp.
Nabil Nakhoul1 insp.
Joann F Fujikawa1 insp.
Stephen C Smith1 insp.
Kelvin Cheung1 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 | 4x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Karl Storz Endoscopy America Inc's 3 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