Mylan, Inc. - March 29, 2010
Issue Date
Mar 29, 2010
Region
Southeast
Category
Drug
$117.00
Address 1
Rd #156, Km 58.8, Lot 24B
Address 2
Caguas West Industrial Pk
City
Caguas
State
PR
Zip/Postal Code
725
Country
US
Inspection Range
Jan 13, 2010 - Mar 29, 2010
Pages
10
First Observation
Control procedures are not established which monitor the output and 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): Jorge L. Lajara and Iraida Ortiz