Dynex Technologies, Inc
Form 483 issued February 18, 2022 · Chantilly, Virginia
- Inspection
- Feb 7 – Feb 18, 2022
- Investigator
- Tiki Dixon
- Observations
- 3
- Pages
- 5
- FEI number
- 1117676
In short: On February 18, 2022, FDA issued a Form 483 with 3 observations to Dynex Technologies, Inc in Chantilly, Virginia (FEI 1117676) after an inspection that ran Feb 7 – Feb 18, 2022. The investigator was Tiki Dixon. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Requirements that must be met by suppliers, contractor s and consultants hav e…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Tiki Dixon
10 documents · 2016–2024
Cites 820.80(a) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in Virginia.
The firmDynex Technologies, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dynex Technologies, Inc?
FDA listed 3 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 Dynex Technologies, Inc?
Tiki Dixon is named on this Form 483, for the inspection of Feb 7 – Feb 18, 2022. Each investigator has a profile showing what they cite most.
When was Dynex Technologies, Inc inspected by FDA?
The inspection ran Feb 7 – Feb 18, 2022, and the Form 483 is dated February 18, 2022.
How do I get the full Form 483 for Dynex 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.