Smaart Medical Systems, Inc
FDA inspection history in Dallas, 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 Dallas, Texas.
Cited most
Across all Smaart Medical Systems observations on file
- 21 CFR 820.30(a)Design controls2
- 21 CFR 8301
- 21 CFR 801.20(a)Label to bear a unique device identifier1
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Smaart Medical Systems file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Dallas, Texas
One Form 483 · 2025 · 13 observations
Latest: Form 483, May 9, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-09 | 483 Form 483 | Dallas, Texas | 13 | $99 |
Investigators on these documents
FEI number 3025620599 · most recent document May 9, 2025
About Smaart Medical Systems, Inc
How many FDA Form 483s has Smaart Medical Systems, Inc received?
FDA Intel has 1 Form 483 on file for Smaart Medical Systems, Inc; the most recent is dated May 9, 2025.
When was Smaart Medical Systems, Inc last inspected by FDA?
The most recent FDA inspection document on file for Smaart Medical Systems, Inc is a Form 483 dated May 9, 2025, for the site in Dallas, Texas.
What did FDA cite at Smaart Medical Systems, Inc?
The regulations cited most in the observations on file for Smaart Medical Systems, Inc are 21 CFR 820.30(a) (Design controls), 2 times; 21 CFR 830, 1 time; 21 CFR 801.20(a) (Label to bear a unique device identifier), 1 time.