AbbVie Biotechnology, Ltd. - March 25, 2019
Issue Date
Mar 25, 2019
Region
Southeast
Category
Drug
$117.00
Contact Name
James Erker
Contact Title
ABL QA Site Director
Address 1
Rd. #2, Km #59.2
Address 2
Abl Building Ab28
City
Barceloneta
State
PR
Zip/Postal Code
00617
Country
United States
Inspection Range
Mar 12, 2019 - Mar 25, 2019
Pages
10
First Observation
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Libia Lugo