Genentech, Inc. - May 21, 2015
Issue Date
May 21, 2015
Region
Pacific
Category
Drug
$117.00
Contact Name
Andy Williams
Contact Title
Senior Director, Facilities Operations, Oceanside Biologics Operations
Address 1
1 Antibody Way
City
Oceanside
State
CA
Zip/Postal Code
92056
Country
United States
Inspection Range
May 11, 2015 - May 21, 2015
Pages
3
First Observation
Your firm's Bulk Dispensing Unit (BDU), filling and packaging operations for Active Pharmaceutical Ingredients (APIs) Actemra SC and IV are deficient.
Investigator(s): Paul Bonneau and Virgilio F. Pacio