Uramix Inc
Form 483 issued May 20, 2025 · Lansdowne, Pennsylvania
- Inspection
- Apr 24 – May 20, 2025
- Investigator
- Edward D. McDonald
- Observations
- 2
- Pages
- 3
- FEI number
- 3001642379
In short: On May 20, 2025, FDA issued a Form 483 with 2 observations to Uramix Inc in Lansdowne, Pennsylvania (FEI 3001642379) after an inspection that ran Apr 24 – May 20, 2025. The investigator was Edward D. McDonald. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Management controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.20(e) (1×) · 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Quality system procedures and instructions…
- 02
Written MDR procedures have not been…
This inspection in context
Edward D. McDonald
8 documents · 2014–2026
Cites 820.20 (management responsibility) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmUramix Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Uramix Inc?
FDA listed 2 observations on this Form 483, mostly about management controls and cAPA. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Uramix Inc?
Edward D. McDonald is named on this Form 483, for the inspection of Apr 24 – May 20, 2025. Each investigator has a profile showing what they cite most.
When was Uramix Inc inspected by FDA?
The inspection ran Apr 24 – May 20, 2025, and the Form 483 is dated May 20, 2025.
How do I get the full Form 483 for Uramix Inc?
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.