FDA 483 - Genentech, Inc. - May 26, 2022

An FDA inspection of Genentech, Inc. in South San Francisco, CA, a drug substance and drug product manufacturer, identified two significant observations. The firm's laboratory controls were found to lack scientifically sound standards, specifically regarding unvalidated hold times for endotoxin samples and infrequent incubator cleaning. Additionally, the Quality Unit failed to adhere to written procedures for the qualification of critical reagents, leading to an improper cell bank potency comparison.