Ultradent Products, Inc.
FDA inspection history in South Jordan, Utah, 2014 to 2020
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2014: one close-out letter and one warning letter; 2017: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One close-out letter and one warning letter, at South Jordan, Utah.
- 2017One Form 483, at South Jordan, Utah.
- 2020One Form 483, at South Jordan, Utah.
- 2020The longest 483 on file: 3 observations over 3 pages at South Jordan, Utah.
Cited most
Across all Ultradent Products observations on file
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.58Maintenance1
The complete Ultradent Products file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
South Jordan, Utah
Two Form 483s, one close-out letter and one warning letter · 2014 to 2020 · 4 observations
Latest: Form 483, Jan 17, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-01-17 | 483 Form 483 | South Jordan, Utah | 3 | $99 |
| 2017-09-15 | 483 Form 483 | South Jordan, Utah | 1 | $99 |
| 2014-11-18 | Close-out Close-out letter | South Jordan, Utah | — | $99 |
| 2014-03-17 | Warning letter Warning letter | South Jordan, Utah | — | $99 |
Investigators on these documents
FEI number 1718912 · most recent document Jan 17, 2020
About Ultradent Products, Inc.
How many FDA Form 483s has Ultradent Products, Inc. received?
FDA Intel has 2 Form 483s on file for Ultradent Products, Inc.; the most recent is dated Jan 17, 2020.
When was Ultradent Products, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Ultradent Products, Inc. is a Form 483 dated Jan 17, 2020, for the site in South Jordan, Utah.
What did FDA cite at Ultradent Products, Inc.?
The regulations cited most in the observations on file for Ultradent Products, Inc. are 21 CFR 211.160(a) (General requirements), 2 times; 21 CFR 211.165(e) (Testing and release for distribution), 1 time; 21 CFR 211.58 (Maintenance), 1 time.
Has Ultradent Products, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ultradent Products, Inc.; the most recent is dated Mar 17, 2014.