Dexta Corporation
Form 483 issued February 3, 2015 · Napa, California
- Inspection
- Jan 20 – Feb 3, 2015
- Investigator
- Jude C. Dike
- Observations
- 7
- Pages
- 4
- FEI number
- 2916273
In short: On February 3, 2015, FDA issued a Form 483 with 7 observations to Dexta Corporation in Napa, California (FEI 2916273) after an inspection that ran Jan 20 – Feb 3, 2015. The investigator was Jude C. Dike. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for acceptance activities have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
This inspection in context
Jude C. Dike
9 documents · 2015–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmDexta Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dexta Corporation?
FDA listed 7 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Dexta Corporation?
Jude C. Dike is named on this Form 483, for the inspection of Jan 20 – Feb 3, 2015. Each investigator has a profile showing what they cite most.
When was Dexta Corporation inspected by FDA?
The inspection ran Jan 20 – Feb 3, 2015, and the Form 483 is dated February 3, 2015.
How do I get the full Form 483 for Dexta Corporation?
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.