Dental Health Associates Of Madison, Ltd
Form 483 issued September 3, 2024 · Fitchburg, Wisconsin
- Inspection
- Sep 3, 2024
- Investigators
- Nicholas Z. Lu· Shawn Choi
- Observations
- 4
- Pages
- 4
- FEI number
- 3008484111
In short: On September 3, 2024, FDA issued a Form 483 with 4 observations to Dental Health Associates Of Madison, Ltd in Fitchburg, Wisconsin (FEI 3008484111) after an inspection that ran Sep 3, 2024. The investigators were Nicholas Z. Lu and Shawn Choi. Most observations concern management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
4 of 4 observations on this 483 concern management controls.
What FDA observed
Preview: the opening words of each observation- 01
The quality policy and quality objectives was/were not established by…
- 02
Procedures for management review…
- 03
A quality plan has…
- 04
Quality system procedures and instructions…
This inspection in context
Nicholas Z. Lu
10 documents · 2018–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmDental Health Associates Of Madison, Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dental Health Associates Of Madison, Ltd?
FDA listed 4 observations on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Dental Health Associates Of Madison, Ltd?
Nicholas Z. Lu and Shawn Choi are named on this Form 483, for the inspection of Sep 3, 2024. Each investigator has a profile showing what they cite most.
When was Dental Health Associates Of Madison, Ltd inspected by FDA?
The inspection ran Sep 3, 2024, and the Form 483 is dated September 3, 2024.
How do I get the full Form 483 for Dental Health Associates Of Madison, Ltd?
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.