Svelte Medical Systems
Form 483 issued June 14, 2021 · New Providence, New Jersey
- Inspection
- May 25 – Jun 14, 2021
- Investigator
- Frank J. Marciniak
- Observations
- 2
- Pages
- 6
- FEI number
- 3008164981
In short: On June 14, 2021, FDA issued a Form 483 with 2 observations to Svelte Medical Systems in New Providence, New Jersey (FEI 3008164981) after an inspection that ran May 25 – Jun 14, 2021. The investigator was Frank J. Marciniak. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 2 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Design output was not…
- 02
Results of the design risk analysis…
This inspection in context
Frank J. Marciniak
7 documents · 2018–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmSvelte Medical Systems history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Svelte Medical Systems?
FDA listed 2 observations on this Form 483, mostly about design 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 Svelte Medical Systems?
Frank J. Marciniak is named on this Form 483, for the inspection of May 25 – Jun 14, 2021. Each investigator has a profile showing what they cite most.
When was Svelte Medical Systems inspected by FDA?
The inspection ran May 25 – Jun 14, 2021, and the Form 483 is dated June 14, 2021.
How do I get the full Form 483 for Svelte Medical Systems?
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.