ELITechGroup, Inc
Form 483 issued May 27, 2015 · Logan, Utah
- Inspection
- May 19 – May 27, 2015
- Investigator
- James R. Montero
- Observations
- 3
- Pages
- 4
- FEI number
- 1717966
In short: On May 27, 2015, FDA issued a Form 483 with 3 observations to ELITechGroup, Inc in Logan, Utah (FEI 1717966) after an inspection that ran May 19 – May 27, 2015. The investigator was James R. Montero. Most observations concern cAPA.
At a glance
3 of 3 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
Complaints involving the possible failure of a device to meet any of its specifications were…
- 03
Corrective and preventive action activities and/or results have…
This inspection in context
James R. Montero
10 documents · 2014–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmELITechGroup, 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 ELITechGroup, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected ELITechGroup, Inc?
James R. Montero is named on this Form 483, for the inspection of May 19 – May 27, 2015. Each investigator has a profile showing what they cite most.
When was ELITechGroup, Inc inspected by FDA?
The inspection ran May 19 – May 27, 2015, and the Form 483 is dated May 27, 2015.
How do I get the full Form 483 for ELITechGroup, 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.