Clariance Inc
Form 483 issued June 4, 2019 · Chicago, Illinois
- Inspection
- May 28 – Jun 4, 2019
- Investigators
- Jesse A. Vazquez· Natasha R. Johnson
- Observations
- 2
- Pages
- 9
- FEI number
- 3009962553
In short: On June 4, 2019, FDA issued a Form 483 with 2 observations to Clariance Inc in Chicago, Illinois (FEI 3009962553) after an inspection that ran May 28 – Jun 4, 2019. The investigators were Jesse A. Vazquez and Natasha R. Johnson. Most observations concern cAPA; the most-cited regulation is 21 CFR 806.20 (records of corrections and removals not required to be reported).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 806.20(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups…
This inspection in context
Jesse A. Vazquez
4 documents · 2013–2019
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
The firmClariance Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.20(b)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clariance Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 806.20 (records of corrections and removals not required to be reported). The opening words of each observation are shown on this page.
Who inspected Clariance Inc?
Jesse A. Vazquez and Natasha R. Johnson are named on this Form 483, for the inspection of May 28 – Jun 4, 2019. Each investigator has a profile showing what they cite most.
When was Clariance Inc inspected by FDA?
The inspection ran May 28 – Jun 4, 2019, and the Form 483 is dated June 4, 2019.
How do I get the full Form 483 for Clariance Inc?
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.