Sterigenics UK Limited
Form 483 issued September 25, 2025
- Inspection
- Sep 22 – Sep 25, 2025
- Investigator
- Frank J. Merciniek
- Observations
- 3
- Pages
- 4
- FEI number
- 3002807091
In short: On September 25, 2025, FDA issued a Form 483 with 3 observations to Sterigenics UK Limited (FEI 3002807091) after an inspection that ran Sep 22 – Sep 25, 2025. The investigator was Frank J. Merciniek. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Corrective and preventive action activities and/or results have…
- 03
Procedures for management review have…
This inspection in context
Frank J. Merciniek
1 document · 2025
Cites 820.100(b) (corrective and preventive action) more than any other section.
The firmSterigenics UK Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sterigenics UK Limited?
FDA listed 3 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Sterigenics UK Limited?
Frank J. Merciniek is named on this Form 483, for the inspection of Sep 22 – Sep 25, 2025. Each investigator has a profile showing what they cite most.
When was Sterigenics UK Limited inspected by FDA?
The inspection ran Sep 22 – Sep 25, 2025, and the Form 483 is dated September 25, 2025.
How do I get the full Form 483 for Sterigenics UK Limited?
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.