FDA 483 - Gener8 - May 05, 2023

An FDA inspection of Gener8, a contract manufacturer in San Jose, CA, from May 2-5, 2023, revealed a significant issue with their quality system. The firm's procedures for servicing products and conducting failure analysis investigations were found to be inadequately defined. Specifically, 5 out of 6 reviewed Returned Material Authorization (RMA) investigations lacked proper documentation.