Patheon Puerto Rico, Inc. - Sept. 3, 2015
Issue Date
Sep 03, 2015
Region
Southeast
Category
Drug
$117.00
Contact Name
Francis Vazquez
Contact Title
Executive Director and General Manager
Address 1
State Rd. 670
Address 2
Km 2.7
City
Manati
State
PR
Zip/Postal Code
00674
Country
United States
Inspection Range
Aug 25, 2015 - Sep 03, 2015
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): Cassandra L. Abellard, Jose E. Melendez, and Doan T. Nguyen