Ultradent Products, Inc.
Form 483 issued September 15, 2017 · South Jordan, Utah
- Investigator
- Haroon Vohra
- Observations
- 1
- Pages
- 2
- FEI number
- 1718912
In short: On September 15, 2017, FDA issued a Form 483 with 1 observation to Ultradent Products, Inc. in South Jordan, Utah (FEI 1718912). The investigator was Haroon Vohra. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.58 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
This inspection in context
Haroon Vohra
3 documents · 2017–2020
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
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 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ultradent Products, Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Ultradent Products, Inc.?
Haroon Vohra is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Ultradent Products, Inc. inspected by FDA?
This Form 483 is dated September 15, 2017.
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.