Kimloerly—C1 ark Corporation
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
- 3003701733
In short: On July 25, 2019, FDA issued a Form 483 with 1 observation to Kimloerly—C1 ark Corporation in Neenah, Wisconsin (FEI 3003701733) 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 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
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 firmKimloerly—C1 ark Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kimloerly—C1 ark Corporation?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Kimloerly—C1 ark Corporation?
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 Kimloerly—C1 ark Corporation 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 Kimloerly—C1 ark Corporation?
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