Neuro Kinetics, Inc
Form 483 issued July 2, 2019 · Pittsburgh, Pennsylvania
- Inspection
- Jun 17 – Jul 2, 2019
- Investigator
- Dennis R. Hock
- Observations
- 4
- Pages
- 4
- FEI number
- 2519945
In short: On July 2, 2019, FDA issued a Form 483 with 4 observations to Neuro Kinetics, Inc in Pittsburgh, Pennsylvania (FEI 2519945) after an inspection that ran Jun 17 – Jul 2, 2019. The investigator was Dennis R. Hock. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 3 of 4 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Design validation did not ensure the device conforms to defined user…
- 02
Acceptance criteria were not established prior to the…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Procedures for acceptance of incoming product have…
This inspection in context
Dennis R. Hock
10 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmNeuro Kinetics, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Neuro Kinetics, Inc?
FDA listed 4 observations on this Form 483, mostly about design controls, cAPA and production & process 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 Neuro Kinetics, Inc?
Dennis R. Hock is named on this Form 483, for the inspection of Jun 17 – Jul 2, 2019. Each investigator has a profile showing what they cite most.
When was Neuro Kinetics, Inc inspected by FDA?
The inspection ran Jun 17 – Jul 2, 2019, and the Form 483 is dated July 2, 2019.
How do I get the full Form 483 for Neuro Kinetics, 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.