Sterigenics U.S., LLC
Form 483 issued December 17, 2024 · Schaumburg, Illinois
- Inspection
- Dec 16 – Dec 17, 2024
- Investigator
- Nicholas Z. Lu
- Observations
- 1
- Pages
- 4
- FEI number
- 1420032
In short: On December 17, 2024, FDA issued a Form 483 with 1 observation to Sterigenics U.S., LLC in Schaumburg, Illinois (FEI 1420032) after an inspection that ran Dec 16 – Dec 17, 2024. The investigator was Nicholas Z. Lu. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action 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 firmSterigenics U.S., LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sterigenics U.S., LLC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Sterigenics U.S., LLC?
Nicholas Z. Lu is named on this Form 483, for the inspection of Dec 16 – Dec 17, 2024. Each investigator has a profile showing what they cite most.
When was Sterigenics U.S., LLC inspected by FDA?
The inspection ran Dec 16 – Dec 17, 2024, and the Form 483 is dated December 17, 2024.
How do I get the full Form 483 for Sterigenics U.S., 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.