Korex Chicago LLC
Form 483 issued February 7, 2025 · Chicago, Illinois
- Inspection
- Jan 27 – Feb 7, 2025
- Investigators
- Nicholas P. Diorio· Travis V. Hull
- Observations
- 6
- Pages
- 6
- FEI number
- 3006458382
In short: On February 7, 2025, FDA issued a Form 483 with 6 observations to Korex Chicago LLC in Chicago, Illinois (FEI 3006458382) after an inspection that ran Jan 27 – Feb 7, 2025. The investigators were Nicholas P. Diorio and Travis V. Hull. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
The written stability program for drug products does not include reliable…
This inspection in context
Nicholas P. Diorio
8 documents · 2013–2025
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Illinois.
The firmKorex Chicago LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Korex Chicago LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Korex Chicago LLC?
Nicholas P. Diorio and Travis V. Hull are named on this Form 483, for the inspection of Jan 27 – Feb 7, 2025. Each investigator has a profile showing what they cite most.
When was Korex Chicago LLC inspected by FDA?
The inspection ran Jan 27 – Feb 7, 2025, and the Form 483 is dated February 7, 2025.
How do I get the full Form 483 for Korex Chicago 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.