Omnilife Science, Inc. - 12/6/2012
Issue Date
Dec 06, 2012
Region
Northeast
Category
Device
$117.00
Address 1
50 O'Connell Way
Address 2
Unit 10
City
East Taunton
State
MA
Zip/Postal Code
02718
Country
United States
Inspection Range
Dec 03, 2012 - Dec 06, 2012
Pages
2
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): John A. Sciacchitano