Amgen Manufacturing Ltd. - Jan. 23, 2015
Issue Date
Jan 23, 2015
Region
Southeast
Category
Drug
$117.00
Contact Name
Robert Maroney
Contact Title
Vice President Site Operations
Address 1
Road #31, Km #24.6
City
Juncos
State
PR
Zip/Postal Code
00777
Country
United States
Inspection Range
Jan 12, 2015 - Jan 23, 2015
Pages
9
First Observation
The current procedures for the monitoring of the environmental conditions in the drug-product aseptic production and the drug-substance production areas do not always establish/include and/or require sample collections which could provide a more accurate and/or more thorough assessment on the microbiological quality and/or condition of the aseptic-filling operation and drug-substance production areas and/or surfaces that are monitored as part of these procedures.
Investigator(s): Dennis Cantellops and Jose A. Cruz-Gonzalez