FDA 483 - Biogenex Laboratories, Inc. - October 06, 2025

During an FDA inspection conducted from October 1-6, 2025, Biogenex Laboratories, Inc., a medical device manufacturer in Fremont, CA, was issued a Form FDA 483 detailing significant quality system deficiencies. The inspection highlighted three main observations requiring corrective action.

First, the company's complaint handling procedures were not adequately implemented. Specifically, 11 out of 13 reviewed complaint records for device failures lacked thorough investigations to determine root causes, and the firm failed to complete required Medical Device Report (MDR) evaluations for multiple complaints involving performance issues with products like antibodies.

Second, Biogenex Laboratories failed to submit MDRs within the mandated 30-day timeframe after becoming aware of information suggesting device malfunctions that could cause serious injury if they recurred. Examples cited included an Anti-BRAF antibody giving inconsistent results and an Anti-CD20 antibody with high background staining.

Finally, the firm's device labels for products such as Anti-Estrogen Receptor-Alpha and Anti-Human Progesterone receptor did not include Unique Device Identifiers (UDI), indicating non-compliance with UDI labeling regulations. The company has acknowledged these observations and promised to correct them, necessitating a comprehensive review and overhaul of its quality system to ensure adherence to the Federal Food, Drug, and Cosmetic Act and related medical device regulations.