Merck & Company, Inc. - April 14, 2011
Issue Date
Apr 14, 2011
Region
Southeast
Category
Drug
$117.00
Address 1
St Rd. #2 Km 60.3 Bo. Sabana Hoyos
City
Arecibo
Zip/Postal Code
00688
Country
PR
Inspection Range
Mar 28, 2011 - Apr 14, 2011
Pages
5
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): Shawn R. Gould, Jose E. Melendez, and Mahesh Ramanadham