Discus Dental LLC
Form 483 issued October 17, 2019 · Ontario, California
- Inspection
- Oct 2 – Oct 17, 2019
- Investigators
- Diane R. Weidley· Marcus F. Yambot
- Observations
- 1
- Pages
- 1
In short: On October 17, 2019, FDA issued a Form 483 with 1 observation to Discus Dental LLC in Ontario, California after an inspection that ran Oct 2 – Oct 17, 2019. The investigators were Diane R. Weidley and Marcus F. Yambot. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Diane R. Weidley
3 documents · 2019–2020
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in California.
The firmDiscus Dental LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Discus Dental LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Discus Dental LLC?
Diane R. Weidley and Marcus F. Yambot are named on this Form 483, for the inspection of Oct 2 – Oct 17, 2019. Each investigator has a profile showing what they cite most.
When was Discus Dental LLC inspected by FDA?
The inspection ran Oct 2 – Oct 17, 2019, and the Form 483 is dated October 17, 2019.
How do I get the full Form 483 for Discus Dental LLC?
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.