Dental Technologies, Inc.
Form 483 issued July 26, 2022 · LINCOLNWOOD, Illinois
- Inspection
- Jul 11 – Jul 26, 2022
- Investigators
- Anders W. Evenson· Michele L. Glendenning· Nicholas Z. Lu
- Observations
- 9
- Pages
- 13
- FEI number
- 1413475
In short: On July 26, 2022, FDA issued a Form 483 with 9 observations to Dental Technologies, Inc. in LINCOLNWOOD, Illinois (FEI 1413475) after an inspection that ran Jul 11 – Jul 26, 2022. The investigators were Anders W. Evenson, Michele L. Glendenning and Nicholas Z. Lu. Most observations concern laboratory controls and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 820.30 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Representative samples are not taken of each shipment of each lot of components…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Written procedures for the cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning…
This inspection in context
Anders W. Evenson
3 documents · 2022–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmDental Technologies, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dental Technologies, Inc.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, design controls and quality system. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Dental Technologies, Inc.?
Anders W. Evenson, Michele L. Glendenning and Nicholas Z. Lu are named on this Form 483, for the inspection of Jul 11 – Jul 26, 2022. Each investigator has a profile showing what they cite most.
When was Dental Technologies, Inc. inspected by FDA?
The inspection ran Jul 11 – Jul 26, 2022, and the Form 483 is dated July 26, 2022.
How do I get the full Form 483 for Dental Technologies, 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.