ACell, Inc - 12/20/2012
Issue Date
Dec 20, 2012
Region
Central
Category
Device
$117.00
Address 1
6640 Eli Whitney Drive
Address 2
Suite 200
City
Colombia
State
MD
Zip/Postal Code
21046
Country
United States
Inspection Range
Nov 28, 2012 - Dec 20, 2012
Pages
3
First Observation
An MDR was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that marketed device may have caused or contributed to death or serious injury.
Investigator(s): Lori S. Lawless and Erin L. McFiren