Isorx Cyclotron Center
Form 483 issued March 13, 2026 · Lubbock, Texas
- Inspection
- Mar 9 – Mar 13, 2026
- Investigators
- Roger F. Zabinski· Ronda R. Loyd Jones
- Observations
- 7
- Pages
- 11
- FEI number
- 3021621451
In short: On March 13, 2026, FDA issued a Form 483 with 7 observations to Isorx Cyclotron Center in Lubbock, Texas (FEI 3021621451) after an inspection that ran Mar 9 – Mar 13, 2026. The investigators were Roger F. Zabinski and Ronda R. Loyd Jones. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and quality system account for 6 of 7 observations.
Most cited: 21 CFR 211.188 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Permitted variations in the amount of component necessary are not reasonable and not specified in the…
- 02
Your batch production record…
- 03
You did not review production records to determine…
- 04
You did not esta blish and follow…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmIsorx Cyclotron Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Isorx Cyclotron Center?
FDA listed 7 observations on this Form 483, mostly about production, quality system and materials. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Isorx Cyclotron Center?
Roger F. Zabinski and Ronda R. Loyd Jones are named on this Form 483, for the inspection of Mar 9 – Mar 13, 2026. Each investigator has a profile showing what they cite most.
When was Isorx Cyclotron Center inspected by FDA?
The inspection ran Mar 9 – Mar 13, 2026, and the Form 483 is dated March 13, 2026.
How do I get the full Form 483 for Isorx Cyclotron Center?
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