Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-07-25.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jul 2019 – 25 Jul 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jun 2017 – 23 Jun 2017 | Medical Devices & Rad Health | 483 | On file |
| 27 Jan 2014 – 30 Jan 2014 | Medical Devices & Rad Health | Clean | |
| 8 Jun 2012 | Not recorded | 483 | View 483 → |
| 2 Mar 2011 | Not recorded | 483 | On file |
| 15 Aug 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2019
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Jennifer S Ness, Mary K Concannon, Nicholas T Domer
25 Jul 2019
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Jennifer S Ness, Mary K Concannon, Nicholas T Domer
8 Jun 2012
21 CFR 820.30(g)
Design validation - production units
Cited by Rebecca L Mullikin, Corey K Reno
8 Jun 2012
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Rebecca L Mullikin, Corey K Reno
8 Jun 2012
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Rebecca L Mullikin, Corey K Reno
Investigators
FDA investigators tied to this site in the record.
Corey K Reno2 insp.
Jennifer S Ness1 insp.
Mary K Concannon1 insp.
Nicholas T Domer1 insp.
MDSAP WilliamsA1 insp.
Richard J Tucker1 insp.
Rebecca L Mullikin1 insp.
Marissa S Henning1 insp.
Kimberly Lewandowski-Walker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kimberly-Clark Corporation's 5 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