FDA 483 - Michelson Laboratories Inc - September 26, 2023

Michelson Laboratories Inc, a contract manufacturing laboratory in Commerce, CA, was cited for significant deficiencies in computer system controls for HPLC machines used in pharmaceutical drug product testing. Observations included a lack of individual access controls, absence of audit trails, deletable data on local drives, and no electronic data backup. These issues indicate severe data integrity concerns regarding pharmaceutical drug product testing.