Amgen Manufacturing Ltd. - April 11, 2019
Issue Date
Apr 11, 2019
Region
Southeast
Category
Device
$117.00
Contact Name
Rayne M. Waller
Contact Title
Vice President, Regional Manufacturing
Address 1
Rd. 31, Km. 24.6
City
Juncos
State
PR
Zip/Postal Code
00777
Country
United States
Inspection Range
Apr 01, 2019 - Apr 11, 2019
Pages
9
First Observation
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Investigator(s): Jennifer Lalama, Jose E. Melendez, and Adaliz Santaliz-Cruz