Sunrise Medical LLC
Form 483 issued May 6, 2016 · Fresno, California
- Inspection
- Apr 25 – May 6, 2016
- Investigator
- Adam S. Freeman
- Observations
- 5
- Pages
- 6
- FEI number
- 2937137
In short: On May 6, 2016, FDA issued a Form 483 with 5 observations to Sunrise Medical LLC in Fresno, California (FEI 2937137) after an inspection that ran Apr 25 – May 6, 2016. The investigator was Adam S. Freeman. Most observations concern cAPA and production & process controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 806.10(a)(1)21 CFR 806.2(d)
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Procedures for corrective and preventive action…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Adam S. Freeman
2 documents · 2016–2017
Cites 806.10(a)(1) (reports of corrections and removals) more than any other section. Most of their documents are for sites in California.
The firmSunrise Medical LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.10(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sunrise Medical LLC?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Sunrise Medical LLC?
Adam S. Freeman is named on this Form 483, for the inspection of Apr 25 – May 6, 2016. Each investigator has a profile showing what they cite most.
When was Sunrise Medical LLC inspected by FDA?
The inspection ran Apr 25 – May 6, 2016, and the Form 483 is dated May 6, 2016.
How do I get the full Form 483 for Sunrise Medical LLC?
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.