American Orthodontics Corporation
Form 483 issued June 16, 2016 · Sheboygan, Wisconsin
- Inspection
- Jun 2 – Jun 16, 2016
- Investigator
- Richard J. Tucker
- Observations
- 3
- Pages
- 3
- FEI number
- 2126683
In short: On June 16, 2016, FDA issued a Form 483 with 3 observations to American Orthodontics Corporation in Sheboygan, Wisconsin (FEI 2126683) after an inspection that ran Jun 2 – Jun 16, 2016. The investigator was Richard J. Tucker. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 3 observations on this 483 concern design controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
- 02
Procedures for design transfer have…
- 03
The acceptance status of product was not identified to indicate conformance or nonconformance with…
This inspection in context
Richard J. Tucker
2 documents · 2015–2016
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Wisconsin.
The firmAmerican Orthodontics Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Orthodontics Corporation?
FDA listed 3 observations on this Form 483, mostly about design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected American Orthodontics Corporation?
Richard J. Tucker is named on this Form 483, for the inspection of Jun 2 – Jun 16, 2016. Each investigator has a profile showing what they cite most.
When was American Orthodontics Corporation inspected by FDA?
The inspection ran Jun 2 – Jun 16, 2016, and the Form 483 is dated June 16, 2016.
How do I get the full Form 483 for American Orthodontics Corporation?
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.