Cognivue Inc.
Form 483 issued June 4, 2019 · Victor, New York
- Inspection
- May 29 – Jun 4, 2019
- Investigator
- Matthew D. Schnittker
- Observations
- 2
- Pages
- 5
- FEI number
- 3014389576
In short: On June 4, 2019, FDA issued a Form 483 with 2 observations to Cognivue Inc. in Victor, New York (FEI 3014389576) after an inspection that ran May 29 – Jun 4, 2019. The investigator was Matthew D. Schnittker. 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(g) (1×) · 820.30(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Validation of device software…
- 02
Procedures for design change have…
This inspection in context
Matthew D. Schnittker
12 documents · 2015–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmCognivue Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cognivue Inc.?
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 Cognivue Inc.?
Matthew D. Schnittker is named on this Form 483, for the inspection of May 29 – Jun 4, 2019. Each investigator has a profile showing what they cite most.
When was Cognivue Inc. inspected by FDA?
The inspection ran May 29 – Jun 4, 2019, and the Form 483 is dated June 4, 2019.
How do I get the full Form 483 for Cognivue 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.