FDA 483 - Life Science Outsourcing, Inc. - December 11, 2025

Life Science Outsourcing, Inc. in Brea, CA, a contract sterilizer, was cited for significant deficiencies in its quality systems during an FDA inspection. Observations included inadequate sterilization process validation, failures in production and process control procedures, insufficient laboratory controls, and issues with equipment maintenance. The firm also failed to thoroughly investigate out-of-specification results and lacked scientific justification for invalidating bioburden findings.