Dental Technologies, Inc.
FDA inspection history across 2 sites, 2011 to 2022
- 2
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2011: one warning letter; 2021: one warning letter and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Lincolnwood, Illinois.
- 2021–22Two Form 483s and one warning letter, at Lincolnwood, Illinois and LINCOLNWOOD, Illinois.
- 2021The longest 483 on file: 12 observations over 23 pages at LINCOLNWOOD, Illinois.
Cited most
Across all Dental Technologies observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 820.30Design controls2
The complete Dental Technologies file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Lincolnwood, Illinois
Two warning letters and one close-out letter · 2011 to 2021
Latest: Warning letter, Nov 30, 2021 →LINCOLNWOOD, Illinois
Two Form 483s · 2021 to 2022 · 21 observations
Latest: Form 483, Jul 26, 2022 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-26 | 483 Form 483 | LINCOLNWOOD, Illinois | 9 | $99 |
| 2021-11-30 | Warning letter Warning letter | Lincolnwood, Illinois | — | $99 |
| 2021-01-20 | 483 Form 483 | LINCOLNWOOD, Illinois | 12 | $99 |
| 2011-09-15 | Warning letter Warning letter | Lincolnwood, Illinois | — | $99 |
| Undated | Close-out Close-out letter | Lincolnwood, Illinois | — | $99 |
Investigators on these documents
Michele L. Glendenning (2)Anders W. Evenson (1)Brian D. Nicholson (1)Nibin Varghese (1)Nicholas Z. Lu (1)Vioela J. Caze (1)
FEI number 1413475 · most recent document Jul 26, 2022
About Dental Technologies, Inc.
How many FDA Form 483s has Dental Technologies, Inc. received?
FDA Intel has 2 Form 483s on file for Dental Technologies, Inc.; the most recent is dated Jul 26, 2022.
When was Dental Technologies, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Dental Technologies, Inc. is a Form 483 dated Jul 26, 2022, for the site in LINCOLNWOOD, Illinois.
What did FDA cite at Dental Technologies, Inc.?
The regulations cited most in the observations on file for Dental Technologies, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.
Has Dental Technologies, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Dental Technologies, Inc.; the most recent is dated Nov 30, 2021.