Contract Pharmacal Corp. - May 20, 2011
Issue Date
May 20, 2011
Region
Northeast
Category
Drug
$117.00
Address 1
135 Adams Ave.
City
Hauppauge
State
NY
Zip/Postal Code
11788-3633
Country
US
Inspection Range
May 02, 2011 - May 20, 2011
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): Robert C. Horan