Pfizer Consumer HealthCare - March 8, 2011
Issue Date
Mar 08, 2011
Region
Southeast
Category
Drug
$117.00
Address 1
St Rd. #3 Km 42.1
City
Guayama
Zip/Postal Code
00784
Country
PR
Inspection Range
Feb 16, 2011 - Mar 08, 2011
Pages
8
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): Jose E. Melendez and Eva Merced