Somnomed Inc
FDA inspection history in Plano, Texas, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Plano, Texas.
Cited most
Across all Somnomed observations on file
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.70(i)Production and process controls1
- 21 CFR 820.80(a)Receiving, in-process, and finished device acceptance1
- 21 CFR 820.90(b)(2)Nonconforming product1
The complete Somnomed file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Plano, Texas
One Form 483 · 2025 · 5 observations
Latest: Form 483, May 23, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-23 | 483 Form 483 | Plano, Texas | 5 | $99 |
Investigators on these documents
FEI number 3005598536 · most recent document May 23, 2025
About Somnomed Inc
How many FDA Form 483s has Somnomed Inc received?
FDA Intel has 1 Form 483 on file for Somnomed Inc; the most recent is dated May 23, 2025.
When was Somnomed Inc last inspected by FDA?
The most recent FDA inspection document on file for Somnomed Inc is a Form 483 dated May 23, 2025, for the site in Plano, Texas.
What did FDA cite at Somnomed Inc?
The regulations cited most in the observations on file for Somnomed Inc are 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.50 (Purchasing controls), 1 time; 21 CFR 820.70(i) (Production and process controls), 1 time.