Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-03-01.
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 |
|---|---|---|---|
| 29 Feb 2024 – 1 Mar 2024 | Biologics | Clean | |
| 6 Jan 2020 | Biologics | Clean | |
| 11 Sep 2017 – 12 Sep 2017 | Biologics | Clean | |
| 29 Aug 2016 – 31 Aug 2016 | Medical Devices & Rad Health | Clean | |
| 22 Feb 2012 | Not recorded | Clean | |
| 9 Nov 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jennifer L Custodio2 insp.
Amy A Johnson1 insp.
Eric J Cunningham1 insp.
David H Smith1 insp.
Charles Chacko1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Katena Products, Inc.'s 1 Form 483
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