FDA EIR - Genentech, Inc. - April 15, 2016

An FDA inspection of Genentech, Inc.'s Hillsboro, OR facility was conducted from April 4 to April 15, 2016. This routine Good Manufacturing Practices (GMP) inspection assessed the sterile biotech drug manufacturer's operations, including the manufacturing, packaging, and labeling of products such as Avastin, Rituxan, Herceptin, and Cathflo Activase. At the conclusion, a Form FDA-483, Inspectional Observations, was issued. The main violations identified were inadequate maintenance of equipment to prevent contamination, potentially affecting drug product safety and quality, and a lack of detailed information in Standard Operating Procedures regarding material use during media fill processes. Other issues discussed with management, though not on the FDA-483, included inconsistencies in documenting laboratory sterility training completion dates and bio-indicator testing discrepancies that led to a procedural change not yet formalized in an SOP. In response, Genentech's management committed to submitting a written response to the FDA's observations within fifteen business days.