Smaart Medical Systems, Inc
Form 483 issued May 9, 2025 · Dallas, Texas
- Inspection
- May 5 – May 9, 2025
- Investigators
- Elizabeth A. Krolczyk· Jocelyn C. Turner
- Observations
- 13
- Pages
- 13
- FEI number
- 3025620599
In short: On May 9, 2025, FDA issued a Form 483 with 13 observations to Smaart Medical Systems, Inc in Dallas, Texas (FEI 3025620599) after an inspection that ran May 5 – May 9, 2025. The investigators were Elizabeth A. Krolczyk and Jocelyn C. Turner. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures for design validation…
- 03
Software used as part of the quality system has not been validated for its intended use…
- 04
Written MDR procedures have…
This inspection in context
Elizabeth A. Krolczyk
6 documents · 2024–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmSmaart Medical Systems, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Smaart Medical Systems, Inc?
FDA listed 13 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Smaart Medical Systems, Inc?
Elizabeth A. Krolczyk and Jocelyn C. Turner are named on this Form 483, for the inspection of May 5 – May 9, 2025. Each investigator has a profile showing what they cite most.
When was Smaart Medical Systems, Inc inspected by FDA?
The inspection ran May 5 – May 9, 2025, and the Form 483 is dated May 9, 2025.
How do I get the full Form 483 for Smaart Medical Systems, Inc?
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