Neuronetrix Solutions, LLC
Form 483 issued November 7, 2022 · Louisville, Kentucky
- Inspection
- Oct 31 – Nov 7, 2022
- Investigator
- Taimane J. Fisher
- Observations
- 9
- Pages
- 7
- FEI number
- 3011184129
In short: On November 7, 2022, FDA issued a Form 483 with 9 observations to Neuronetrix Solutions, LLC in Louisville, Kentucky (FEI 3011184129) after an inspection that ran Oct 31 – Nov 7, 2022. The investigator was Taimane J. Fisher. Most observations concern cAPA and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and records & documents account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 02
Corrective and preventive action activities and/or results have…
- 03
Products that do not conform to specifications…
- 04
A device history record has…
This inspection in context
Taimane J. Fisher
3 documents · 2020–2025
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Kentucky.
The firmNeuronetrix Solutions, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Neuronetrix Solutions, LLC?
FDA listed 9 observations on this Form 483, mostly about cAPA, records & documents and 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 Neuronetrix Solutions, LLC?
Taimane J. Fisher is named on this Form 483, for the inspection of Oct 31 – Nov 7, 2022. Each investigator has a profile showing what they cite most.
When was Neuronetrix Solutions, LLC inspected by FDA?
The inspection ran Oct 31 – Nov 7, 2022, and the Form 483 is dated November 7, 2022.
How do I get the full Form 483 for Neuronetrix Solutions, LLC?
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.