Chemolee Laboratories - December 21, 2009
Issue Date
Dec 21, 2009
Region
Southwest
Category
Drug
$117.00
Address 1
3820 Conflans Rd.
City
Irving
State
TX
Zip/Postal Code
75061-3915
Country
US
Inspection Range
Nov 23, 2009 - Dec 21, 2009
Pages
11
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): Martha S. Baldwin and Rhonda L. Dash