Radiation Products Design,Inc
Form 483 issued March 4, 2026 · Albertville, Minnesota
- Inspection
- Mar 3 – Mar 4, 2026
- Investigator
- Christina L. Bigham
- Observations
- 1
- Pages
- 3
- FEI number
- 2182762
In short: On March 4, 2026, FDA issued a Form 483 with 1 observation to Radiation Products Design,Inc in Albertville, Minnesota (FEI 2182762) after an inspection that ran Mar 3 – Mar 4, 2026. The investigator was Christina L. Bigham. The most-cited regulation is 21 CFR 7.1 (scope).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.1
One or more processes for risk management in product realization have…
This inspection in context
Christina L. Bigham
11 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmRadiation Products Design,Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Radiation Products Design,Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 7.1 (scope). The opening words of each observation are shown on this page.
Who inspected Radiation Products Design,Inc?
Christina L. Bigham is named on this Form 483, for the inspection of Mar 3 – Mar 4, 2026. Each investigator has a profile showing what they cite most.
When was Radiation Products Design,Inc inspected by FDA?
The inspection ran Mar 3 – Mar 4, 2026, and the Form 483 is dated March 4, 2026.
How do I get the full Form 483 for Radiation Products Design,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.