Truer Medical Inc
Form 483 issued February 13, 2026 · Orange, California
- Inspection
- Feb 10 – Feb 13, 2026
- Investigator
- Jordan I. Abel
- Observations
- 1
- Pages
- 3
- FEI number
- 3003240904
In short: On February 13, 2026, FDA issued a Form 483 with 1 observation to Truer Medical Inc in Orange, California (FEI 3003240904) after an inspection that ran Feb 10 – Feb 13, 2026. The investigator was Jordan I. Abel. The most-cited regulation is 21 CFR 7.3 (definitions).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.3.10
A design and development file was not maintained for each medical device type…
This inspection in context
Jordan I. Abel
1 document · 2026
Cites ISO 13485:2016 Clause 7.3.10 (definitions) more than any other section. Most of their documents are for sites in California.
The firmTruer Medical Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Truer Medical Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 7.3 (definitions). The opening words of each observation are shown on this page.
Who inspected Truer Medical Inc?
Jordan I. Abel is named on this Form 483, for the inspection of Feb 10 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was Truer Medical Inc inspected by FDA?
The inspection ran Feb 10 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for Truer Medical 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.