Miramar Labs, Inc
Form 483 issued August 17, 2015 · Santa Clara, California
- Inspection
- Jul 22 – Aug 17, 2015
- Investigator
- Alla Dubrovsky
- Observations
- 4
- Pages
- 4
- FEI number
- 3008082710
In short: On August 17, 2015, FDA issued a Form 483 with 4 observations to Miramar Labs, Inc in Santa Clara, California (FEI 3008082710) after an inspection that ran Jul 22 – Aug 17, 2015. The investigator was Alla Dubrovsky. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
CAPA and design controls account for 4 of 4 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of recaving or otherwise becoming aware of…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Design validation did not ensure the device conforms to defined user…
- 04
Risk analysis is…
This inspection in context
Alla Dubrovsky
1 document · 2015
Cites 803.50(a)(1) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in California.
The firmMiramar Labs, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Miramar Labs, Inc?
FDA listed 4 observations on this Form 483, mostly about cAPA and design controls. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Miramar Labs, Inc?
Alla Dubrovsky is named on this Form 483, for the inspection of Jul 22 – Aug 17, 2015. Each investigator has a profile showing what they cite most.
When was Miramar Labs, Inc inspected by FDA?
The inspection ran Jul 22 – Aug 17, 2015, and the Form 483 is dated August 17, 2015.
How do I get the full Form 483 for Miramar Labs, 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.