Isotopia Molecular Imaging
Form 483 issued November 8, 2022 · Yavne, Israel
- Inspection
- Oct 30 – Nov 8, 2022
- Investigators
- Gavin T. Cua· Jacob G. Lutz
- Observations
- 1
- Pages
- 2
- FEI number
- 1000234390
In short: On November 8, 2022, FDA issued a Form 483 with 1 observation to Isotopia Molecular Imaging in Yavne, Israel (FEI 1000234390) after an inspection that ran Oct 30 – Nov 8, 2022. The investigators were Gavin T. Cua and Jacob G. Lutz. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Gavin T. Cua
9 documents · 2022–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmIsotopia Molecular Imaging history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Isotopia Molecular Imaging?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Isotopia Molecular Imaging?
Gavin T. Cua and Jacob G. Lutz are named on this Form 483, for the inspection of Oct 30 – Nov 8, 2022. Each investigator has a profile showing what they cite most.
When was Isotopia Molecular Imaging inspected by FDA?
The inspection ran Oct 30 – Nov 8, 2022, and the Form 483 is dated November 8, 2022.
How do I get the full Form 483 for Isotopia Molecular Imaging?
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.