LED Technologies, LLC - April 22,2009
Issue Date
Apr 22, 2009
Region
Southwest
Category
Device
$117.00
Address 1
133 County Rd. 17
City
Elizabeth
State
CO
Zip/Postal Code
80107
Country
US
Inspection Range
Apr 14, 2009 - Apr 22, 2009
Pages
6
First Observation
Procedures have not been established to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality Systems regulation.
Investigator(s): Thai Duong and Janet Pulver