Soma Technology Inc.
Form 483 issued February 18, 2026 · Bloomfield, Connecticut
- Inspection
- Feb 18, 2026
- Investigator
- Eric C. Schmitt
- Observations
- 1
- Pages
- 4
- FEI number
- 1000634785
In short: On February 18, 2026, FDA issued a Form 483 with 1 observation to Soma Technology Inc. in Bloomfield, Connecticut (FEI 1000634785) after an inspection that ran Feb 18, 2026. The investigator was Eric C. Schmitt. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not…
This inspection in context
Eric C. Schmitt
3 documents · 2022–2026
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in Connecticut.
The firmSoma Technology Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Soma Technology Inc.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Soma Technology Inc.?
Eric C. Schmitt is named on this Form 483, for the inspection of Feb 18, 2026. Each investigator has a profile showing what they cite most.
When was Soma Technology Inc. inspected by FDA?
The inspection ran Feb 18, 2026, and the Form 483 is dated February 18, 2026.
How do I get the full Form 483 for Soma Technology 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.