Newman Medical
Form 483 issued May 31, 2019 · Arvada, Colorado
- Inspection
- May 28 – May 31, 2019
- Investigator
- Vicky L. Cruz
- Observations
- 1
- Pages
- 6
- FEI number
- 3006265099
In short: On May 31, 2019, FDA issued a Form 483 with 1 observation to Newman Medical in Arvada, Colorado (FEI 3006265099) after an inspection that ran May 28 – May 31, 2019. The investigator was Vicky L. Cruz. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.80(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for finished device acceptance have…
This inspection in context
Vicky L. Cruz
2 documents · 2017–2019
Cites 820.80(b) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in Colorado.
The firmNewman Medical history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Newman Medical?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected Newman Medical?
Vicky L. Cruz is named on this Form 483, for the inspection of May 28 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was Newman Medical inspected by FDA?
The inspection ran May 28 – May 31, 2019, and the Form 483 is dated May 31, 2019.
How do I get the full Form 483 for Newman Medical?
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.