Venus Concept
Form 483 issued January 16, 2020 · San Jose, California
- Inspection
- Jan 13 – Jan 16, 2020
- Investigator
- Marcia G. Evans
- Observations
- 2
- Pages
- 5
- FEI number
- 3006515340
In short: On January 16, 2020, FDA issued a Form 483 with 2 observations to Venus Concept in San Jose, California (FEI 3006515340) after an inspection that ran Jan 13 – Jan 16, 2020. The investigator was Marcia G. Evans. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(b) (1×) · 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Complaint files are not…
This inspection in context
Marcia G. Evans
3 documents · 2019–2020
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in California.
The firmVenus Concept history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Venus Concept?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Venus Concept?
Marcia G. Evans is named on this Form 483, for the inspection of Jan 13 – Jan 16, 2020. Each investigator has a profile showing what they cite most.
When was Venus Concept inspected by FDA?
The inspection ran Jan 13 – Jan 16, 2020, and the Form 483 is dated January 16, 2020.
How do I get the full Form 483 for Venus Concept?
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.