FDA 483 - Genentech, Inc. - October 18, 2017

Genentech, Inc. in Oceanside, CA, a bulk drug substance manufacturer, was cited for two observations during an FDA inspection. The inspection revealed facility deficiencies including brownish residue, rust stains, and peeling caulking in manufacturing and weighing areas. Additionally, issues were noted in the Supplier Quality Management group regarding tracking actions where the owner and quality individual were the same, leading to potential conflicts of interest in approvals and extensions.