Dental Technologies, Inc.
Form 483 issued January 20, 2021 · LINCOLNWOOD, Illinois
- Inspection
- Dec 7, 2020 – Jan 20, 2021
- Investigators
- Brian D. Nicholson· Michele L. Glendenning· Nibin Varghese
- Observations
- 12
- Pages
- 23
- FEI number
- 1413475
In short: On January 20, 2021, FDA issued a Form 483 with 12 observations to Dental Technologies, Inc. in LINCOLNWOOD, Illinois (FEI 1413475) after an inspection that ran Dec 7, 2020 – Jan 20, 2021. The investigators were Brian D. Nicholson, Michele L. Glendenning, Nibin Varghese and Vioela J. Caze. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
There are no written procedures for production and process control designed to assure that the drug…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dental Technologies, Inc.?
FDA listed 12 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Dental Technologies, Inc.?
Brian D. Nicholson, Michele L. Glendenning, Nibin Varghese and Vioela J. Caze are named on this Form 483, for the inspection of Dec 7, 2020 – Jan 20, 2021. Each investigator has a profile showing what they cite most.
When was Dental Technologies, Inc. inspected by FDA?
The inspection ran Dec 7, 2020 – Jan 20, 2021, and the Form 483 is dated January 20, 2021.
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.