Kimberly-Clark Corp
Form 483 issued July 25, 2019 · Neenah, Wisconsin
- Inspection
- Jul 9 – Jul 25, 2019
- Investigators
- Jennifer S. Ness· Nicholas T. Domer
- Observations
- 1
- Pages
- 4
- FEI number
- 1000139864
In short: On July 25, 2019, FDA issued a Form 483 with 1 observation to Kimberly-Clark Corp in Neenah, Wisconsin (FEI 1000139864) after an inspection that ran Jul 9 – Jul 25, 2019. The investigators were Jennifer S. Ness and Nicholas T. Domer. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.90(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
This inspection in context
Jennifer S. Ness
5 documents · 2015–2019
Cites 820.90 (nonconforming product) more than any other section. Most of their documents are for sites in Wisconsin.
The firmKimberly-Clark Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kimberly-Clark Corp?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Kimberly-Clark Corp?
Jennifer S. Ness and Nicholas T. Domer are named on this Form 483, for the inspection of Jul 9 – Jul 25, 2019. Each investigator has a profile showing what they cite most.
When was Kimberly-Clark Corp inspected by FDA?
The inspection ran Jul 9 – Jul 25, 2019, and the Form 483 is dated July 25, 2019.
How do I get the full Form 483 for Kimberly-Clark Corp?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.