Novarad Corporation
Form 483 issued March 30, 2016 · American Fork, Utah
- Inspection
- Mar 14 – Mar 30, 2016
- Investigator
- James R. Montero
- Observations
- 7
- Pages
- 5
- FEI number
- 1000117423
In short: On March 30, 2016, FDA issued a Form 483 with 7 observations to Novarad Corporation in American Fork, Utah (FEI 1000117423) after an inspection that ran Mar 14 – Mar 30, 2016. The investigator was James R. Montero. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and production & process controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The names, addresses and telephone numbers of all domestic and foreign consignees of devices subject to…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 04
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 firmNovarad Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.10(c)(11)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novarad Corporation?
FDA listed 7 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Novarad Corporation?
James R. Montero is named on this Form 483, for the inspection of Mar 14 – Mar 30, 2016. Each investigator has a profile showing what they cite most.
When was Novarad Corporation inspected by FDA?
The inspection ran Mar 14 – Mar 30, 2016, and the Form 483 is dated March 30, 2016.
How do I get the full Form 483 for Novarad Corporation?
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