LNK International, Inc. - Jan, 17, 2014
Issue Date
Jan 17, 2014
Region
Northeast
Category
Drug
$117.00
Contact Name
Pankaj S. Chudgar
Contact Title
President
Address 1
40 & 60 Arkay Dr.
City
Hauppauge
State
NY
Zip/Postal Code
11788-3708
Country
United States
Inspection Range
Jan 13, 2014 - Jan 17, 2014
Pages
4
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): Justin A. Boyd and Robert C. Horan