MicroTransponder, Inc
Form 483 issued March 19, 2026 · Lakeway, Texas
- Inspection
- Mar 16 – Mar 19, 2026
- Investigator
- Jacey Roy
- Observations
- 1
- Pages
- 3
- FEI number
- 3012309950
In short: On March 19, 2026, FDA issued a Form 483 with 1 observation to MicroTransponder, Inc in Lakeway, Texas (FEI 3012309950) after an inspection that ran Mar 16 – Mar 19, 2026. The investigator was Jacey Roy. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Jacey Roy
1 document · 2026
Cites 803.50(a)(1) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Texas.
The firmMicroTransponder, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MicroTransponder, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected MicroTransponder, Inc?
Jacey Roy is named on this Form 483, for the inspection of Mar 16 – Mar 19, 2026. Each investigator has a profile showing what they cite most.
When was MicroTransponder, Inc inspected by FDA?
The inspection ran Mar 16 – Mar 19, 2026, and the Form 483 is dated March 19, 2026.
How do I get the full Form 483 for MicroTransponder, 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.