Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-05.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2020 – 5 Feb 2020 | Medical Devices & Rad Health | Clean | |
| 19 Jan 2016 – 26 Jan 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Jun 2012 | Not recorded | Clean | |
| 12 Oct 2011 | Not recorded | WL | View 483 → |
| 14 Sep 2009 | Not recorded | Clean | |
| 16 Jun 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jan 2016
21 CFR 820.80(a)
Lack of or inadequate procedures - Acceptance activities
Cited by Shondra N Gipson, Mary A Millner
12 Oct 2011
21 CFR 820.70(b)
Production and Process Change Procedures, lack of or Inad.
Cited by Teresa Bills
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | 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(a) | 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 Kentron Health Care Inc's 2 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