Somnomed Inc
Form 483 issued May 23, 2025 · Plano, Texas
- Inspection
- May 20 – May 23, 2025
- Investigators
- Katherine M. Thames· Yuliana Hernandez-Magana
- Observations
- 5
- Pages
- 6
- FEI number
- 3005598536
In short: On May 23, 2025, FDA issued a Form 483 with 5 observations to Somnomed Inc in Plano, Texas (FEI 3005598536) after an inspection that ran May 20 – May 23, 2025. The investigators were Katherine M. Thames and Yuliana Hernandez-Magana. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
3 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for acceptance activities have…
- 03
Software used as part of the quality system has not been validated for its intended use…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Katherine M. Thames
6 documents · 2025–2026
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Texas.
The firmSomnomed Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Somnomed Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected Somnomed Inc?
Katherine M. Thames and Yuliana Hernandez-Magana are named on this Form 483, for the inspection of May 20 – May 23, 2025. Each investigator has a profile showing what they cite most.
When was Somnomed Inc inspected by FDA?
The inspection ran May 20 – May 23, 2025, and the Form 483 is dated May 23, 2025.
How do I get the full Form 483 for Somnomed Inc?
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