Brius Technologies Inc
Form 483 issued October 7, 2024 · Carrollton, Texas
- Inspection
- Oct 1 – Oct 7, 2024
- Investigators
- Elizabeth A. Krolczyk· Katlin N. Stubbs
- Observations
- 5
- Pages
- 7
- FEI number
- 3014680924
In short: On October 7, 2024, FDA issued a Form 483 with 5 observations to Brius Technologies Inc in Carrollton, Texas (FEI 3014680924) after an inspection that ran Oct 1 – Oct 7, 2024. The investigators were Elizabeth A. Krolczyk and Katlin N. Stubbs. Most observations concern cAPA and production & process controls.
At a glance
4 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Corrective and preventive action activities and/or results have…
- 03
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 04
Procedures have not been adequately established to control product that does not…
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 firmBrius Technologies Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brius Technologies Inc?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Brius Technologies Inc?
Elizabeth A. Krolczyk and Katlin N. Stubbs are named on this Form 483, for the inspection of Oct 1 – Oct 7, 2024. Each investigator has a profile showing what they cite most.
When was Brius Technologies Inc inspected by FDA?
The inspection ran Oct 1 – Oct 7, 2024, and the Form 483 is dated October 7, 2024.
How do I get the full Form 483 for Brius Technologies Inc?
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.