Amgen Manufacturing Ltd. - Aug. 6, 2018
Issue Date
Aug 06, 2018
Region
Southeast
Category
Drug
$117.00
Contact Name
Kerry Ingalls
Contact Title
Vice President Site Operations
Address 1
Rd. 31, Km 24.6
City
Juncos
State
PR
Zip/Postal Code
00777
Country
United States
Inspection Range
Jul 23, 2018 - Aug 06, 2018
Pages
3
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Investigator(s): Vilmary Negron Rodriguez