483
Gener8Gener8 – FDA 483, May 5, 2023
Record Details
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.
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