Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-01.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jul 2024 – 1 Aug 2024 | Medical Devices & Rad Health | Clean | |
| 13 Sep 2022 – 15 Sep 2022 | Medical Devices & Rad Health | Clean | |
| 29 Nov 2021 – 2 Dec 2021 | Medical Devices & Rad Health | 483 | On file |
| 12 Jul 2021 – 16 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Dec 2017 – 6 Dec 2017 | Medical Devices & Rad Health | Clean | |
| 27 Mar 2017 – 31 Mar 2017 | Medical Devices & Rad Health | 483 | On file |
| 25 Mar 2014 – 28 Mar 2014 | Medical Devices & Rad Health | Clean | |
| 12 Feb 2010 | Not recorded | Clean | |
| 18 Nov 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jul 2021
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Jennifer S Ness, Clifford F Long
16 Jul 2021
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Jennifer S Ness, Clifford F Long
Investigators
FDA investigators tied to this site in the record.
Clifford F Long3 insp.
Edward E Lockwood2 insp.
Hammam A Abdallah1 insp.
Ralph W Jerndal1 insp.
Jennifer S Ness1 insp.
Mary K Concannon1 insp.
Eric T Huebler1 insp.
Brittany D Terhar1 insp.
Andrew A Hoopes1 insp.
Candace S Tucker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Katecho LLC's 3 Form 483s
Source PDFs 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