Sorin Group USA, Inc
Form 483 issued March 30, 2016 · Arvada, Colorado
- Inspection
- Mar 9 – Mar 30, 2016
- Investigator
- Amanda S. Zorn
- Observations
- 3
- Pages
- 6
- FEI number
- 1718850
In short: On March 30, 2016, FDA issued a Form 483 with 3 observations to Sorin Group USA, Inc in Arvada, Colorado (FEI 1718850) after an inspection that ran Mar 9 – Mar 30, 2016. The investigator was Amanda S. Zorn. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
- 02
Procedures have not been established to control product that does not…
- 03
Sampling plans are not based…
This inspection in context
Amanda S. Zorn
3 documents · 2014–2016
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmSorin Group USA, Inc 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 Sorin Group USA, Inc?
FDA listed 3 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 Sorin Group USA, Inc?
Amanda S. Zorn is named on this Form 483, for the inspection of Mar 9 – Mar 30, 2016. Each investigator has a profile showing what they cite most.
When was Sorin Group USA, Inc inspected by FDA?
The inspection ran Mar 9 – Mar 30, 2016, and the Form 483 is dated March 30, 2016.
How do I get the full Form 483 for Sorin Group USA, 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.