Dental Alliance Holdings LLC
Form 483 issued October 24, 2024 · Albany, Oregon
- Inspection
- Oct 21 – Oct 24, 2024
- Investigators
- Cecilia H. Kieu· Jason K. Loo
- Observations
- 4
- Pages
- 5
- FEI number
- 3003422682
In short: On October 24, 2024, FDA issued a Form 483 with 4 observations to Dental Alliance Holdings LLC in Albany, Oregon (FEI 3003422682) after an inspection that ran Oct 21 – Oct 24, 2024. The investigators were Cecilia H. Kieu and Jason K. Loo. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Equipment used in the manufacture, processing, packing or holding of ding products is not of appropriate…
- 04
Buildings used in the manufacture, processing, packing, or holding of a ding product do not have…
This inspection in context
Cecilia H. Kieu
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmDental Alliance Holdings LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dental Alliance Holdings LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Dental Alliance Holdings LLC?
Cecilia H. Kieu and Jason K. Loo are named on this Form 483, for the inspection of Oct 21 – Oct 24, 2024. Each investigator has a profile showing what they cite most.
When was Dental Alliance Holdings LLC inspected by FDA?
The inspection ran Oct 21 – Oct 24, 2024, and the Form 483 is dated October 24, 2024.
How do I get the full Form 483 for Dental Alliance Holdings LLC?
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.