Capsule Tech, Inc. - 4/13/2012
Issue Date
Apr 13, 2012
Region
Northeast
Category
Device
$117.00
Address 1
300 Brickstone Sq
City
Andover
State
MA
Zip/Postal Code
01810
Country
United States
Inspection Range
Apr 11, 2012 - Apr 13, 2012
Pages
2
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
Investigator(s): John A. Sciacchitano