Dental Arts Laboratories Inc
Form 483 issued July 18, 2018 · Peoria, Illinois
- Inspection
- Jul 16 – Jul 18, 2018
- Investigator
- Maksim A. Levenchuk
- Observations
- 2
- Pages
- 6
- FEI number
- 3002922620
In short: On July 18, 2018, FDA issued a Form 483 with 2 observations to Dental Arts Laboratories Inc in Peoria, Illinois (FEI 3002922620) after an inspection that ran Jul 16 – Jul 18, 2018. The investigator was Maksim A. Levenchuk. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Maksim A. Levenchuk
2 documents · 2017–2018
Cites 820.75(a) (process validation) more than any other section. Most of their documents are for sites in Illinois.
The firmDental Arts Laboratories Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dental Arts Laboratories Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Dental Arts Laboratories Inc?
Maksim A. Levenchuk is named on this Form 483, for the inspection of Jul 16 – Jul 18, 2018. Each investigator has a profile showing what they cite most.
When was Dental Arts Laboratories Inc inspected by FDA?
The inspection ran Jul 16 – Jul 18, 2018, and the Form 483 is dated July 18, 2018.
How do I get the full Form 483 for Dental Arts Laboratories 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.