FDA 483 - Biocon Generics Inc. - October 10, 2025

During an inspection of Biocon Generics Inc. in Cranbury, NJ, the FDA observed a significant issue regarding the firm's adherence to warehousing procedures for drug products. Specifically, the logbook for temperature and humidity monitoring in the drug product storage area lacked required personnel and reviewer signatures. This indicates a failure to follow established SOPs for data recording and verification.