Oak Ridge Products
Form 483 issued September 30, 2022 · McHenry, Illinois
- Inspection
- Sep 28 – Sep 30, 2022
- Investigator
- Nicholas Z. Lu
- Observations
- 8
- Pages
- 6
- FEI number
- 1419823
In short: On September 30, 2022, FDA issued a Form 483 with 8 observations to Oak Ridge Products in McHenry, Illinois (FEI 1419823) after an inspection that ran Sep 28 – Sep 30, 2022. The investigator was Nicholas Z. Lu. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procediues for collective and preventive action have…
- 03
Written MDR procedures have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
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 firmOak Ridge Products history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oak Ridge Products?
FDA listed 8 observations on this Form 483, mostly about cAPA, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected Oak Ridge Products?
Nicholas Z. Lu is named on this Form 483, for the inspection of Sep 28 – Sep 30, 2022. Each investigator has a profile showing what they cite most.
When was Oak Ridge Products inspected by FDA?
The inspection ran Sep 28 – Sep 30, 2022, and the Form 483 is dated September 30, 2022.
How do I get the full Form 483 for Oak Ridge Products?
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.