Discus Dental LLC
Form 483 issued November 23, 2015 · Ontario, California
- Inspection
- Nov 3 – Nov 23, 2015
- Investigator
- Carla J. Lundi
- Observations
- 10
- Pages
- 7
- FEI number
- 1000582314
In short: On November 23, 2015, FDA issued a Form 483 with 10 observations to Discus Dental LLC in Ontario, California (FEI 1000582314) after an inspection that ran Nov 3 – Nov 23, 2015. The investigator was Carla J. Lundi. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 7 of 10 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The establishment of specifications, standards, sampling plans, test procedures, and laboratory control mechanisms including any changes…
- 02
The written stability program for drug products does not include reliable, meaningful…
- 03
Laboratory controls do not include a determination of conformance to appropriate…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Carla J. Lundi
9 documents · 2009–2021
Cites 211.160 (general requirements) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Discus Dental LLC?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Discus Dental LLC?
Carla J. Lundi is named on this Form 483, for the inspection of Nov 3 – Nov 23, 2015. Each investigator has a profile showing what they cite most.
When was Discus Dental LLC inspected by FDA?
The inspection ran Nov 3 – Nov 23, 2015, and the Form 483 is dated November 23, 2015.
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.