KBD, Inc. - July 25, 2011
Issue Date
Jul 25, 2011
Region
Central
Category
Device
$117.00
Address 1
2550 American Ct.
City
Crescent Springs
State
KY
Zip/Postal Code
41017
Country
US
Inspection Range
Jul 05, 2011 - Jul 25, 2011
Pages
9
First Observation
Your firm has introduced or delivered for introduction into interstate commerce … Fluorescent Vitamin D lamp devices that have been significantly changed or modified in design without submitting a premarket notification to FDA, as required by 21 CFR 807.81(a)(3).
Investigator(s): Maribeth G. Grattan and Malik S. Qaiser