Grifols Biologicals, LLC - Sept. 12, 2019
Issue Date
Sep 12, 2019
Region
Pacific
Category
Drug
$117.00
Contact Name
Guillermo Zuniga
Contact Title
President
Address 1
5555 Valley Blvd.
City
Los Angeles
State
CA
Zip/Postal Code
90032
Country
United States
Inspection Range
Aug 27, 2019 - Sep 12, 2019
Pages
10
First Observation
Control procedures are not established which monitors the output and validated performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process materials and drug products.
Investigator(s): Omotunde O. Osunsanmi