Ultradent Products, Inc.
Form 483 issued January 17, 2020 · South Jordan, Utah
- Inspection
- Jan 13 – Jan 17, 2020
- Investigator
- Nayan J. Patel
- Observations
- 3
- Pages
- 3
- FEI number
- 1718912
In short: On January 17, 2020, FDA issued a Form 483 with 3 observations to Ultradent Products, Inc. in South Jordan, Utah (FEI 1718912) after an inspection that ran Jan 13 – Jan 17, 2020. The investigator was Nayan J. Patel. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy and reproducibility of test methods…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 03
Established test procedures and laboratory control mechanisms are not followed and documented at…
This inspection in context
Nayan J. Patel
11 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Utah.
The firmUltradent Products, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ultradent Products, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Ultradent Products, Inc.?
Nayan J. Patel is named on this Form 483, for the inspection of Jan 13 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was Ultradent Products, Inc. inspected by FDA?
The inspection ran Jan 13 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
How do I get the full Form 483 for Ultradent Products, 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.