Vivos Therapeutics, Inc
Form 483 issued August 27, 2020 · Highlands Ranch, Colorado
- Inspection
- Aug 24 – Aug 27, 2020
- Investigator
- Matthew M. Vernon
- Observations
- 2
- Pages
- 5
- FEI number
- 3013530385
In short: On August 27, 2020, FDA issued a Form 483 with 2 observations to Vivos Therapeutics, Inc in Highlands Ranch, Colorado (FEI 3013530385) after an inspection that ran Aug 24 – Aug 27, 2020. The investigator was Matthew M. Vernon. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.30(j)21 CFR 82021 CFR 820.30(b)21 CFR 820.30(c)21 CFR 820.30(d)21 CFR 820.30(e)21 CFR 820.30(f)21 CFR 820.30(g)21 CFR 820.30(h)
Observation 1: scanned text, readable in the full document.
- 0221 CFR 820.100(a)21 CFR 820.10021 CFR 820.100(a)(2)21 CFR 820.100(a)(4)21 CFR 820.100(a)(3)21 CFR 820.100(a)(5)
Procedures for collective and preventive action have…
This inspection in context
Matthew M. Vernon
6 documents · 2020–2026
Cites 820.20(b)(3) (management responsibility) more than any other section. Most of their documents are for sites in Colorado.
The firmVivos Therapeutics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vivos Therapeutics, Inc?
FDA listed 2 observations on this Form 483, mostly about design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Vivos Therapeutics, Inc?
Matthew M. Vernon is named on this Form 483, for the inspection of Aug 24 – Aug 27, 2020. Each investigator has a profile showing what they cite most.
When was Vivos Therapeutics, Inc inspected by FDA?
The inspection ran Aug 24 – Aug 27, 2020, and the Form 483 is dated August 27, 2020.
How do I get the full Form 483 for Vivos Therapeutics, 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.