United 1 International Laboratories, LLC - August 18, 2010
Issue Date
Aug 18, 2010
Region
Southwest
Category
Drug
$117.00
Address 1
4641 Nall Rd.
City
Farmers Branch
State
TX
Zip/Postal Code
75244-4618
Country
US
Inspection Range
Aug 11, 2010 - Aug 18, 2010
Pages
6
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): Adrian Rodriguez and Trina K. Vick