Genentech, Inc. – FDA EIR, Jun 27, 2012

An FDA inspection of Genentech, Inc.'s Hillsboro, OR facility was conducted from June 19-27, 2012. This pre-approval inspection focused on the drug product manufacturing area, quality control laboratories, and warehouse operations, specifically for certain drug products. The inspection followed regulatory guidelines for therapeutic drug products and pre-approval investigations. The inspection identified nine significant observations, documented on a Form FDA 483. Key issues included a lack of environmental monitoring for non-viable particles and air velocity in vial filling lines, absence of a predetermined HEPA filter replacement schedule, and inadequate assurance regarding the suitability of compressed air for vial drying. Furthermore, the automated visual inspection machines lacked appropriate validation schedules, and the adequacy of their challenge kits could not be verified. Deficiencies were also noted in the electronic document management system (EDMS) regarding validation of current GMP documents, and sampling procedures lacked clear descriptions of random sampling. The operation and cleaning procedures for an inspection machine were found inadequate. A recurring concern was the attribution of multiple discrepancies to "human error" without corresponding recommendations for retraining, highlighting a systemic issue in corrective actions. Genentech is required to address these observations through comprehensive corrective and preventive actions.