OraLabs, Incorporated - August 11, 2010
Issue Date
Aug 11, 2010
Region
Southwest
Category
Drug
$117.00
Address 1
18565 E. Plaza Dr.
City
Parker
State
CO
Zip/Postal Code
80134
Country
US
Inspection Range
Jul 27, 2010 - Aug 11, 2010
Pages
9
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Matthew R. Dionne and Tamara L. Setzer