FDA 483 - Life Science Outsourcing, Inc. - November 12, 2020

Life Science Outsourcing, Inc. in Brea, CA, a contract sterilizer, received a Form 483 with three observations during an FDA inspection. The inspection revealed deficiencies in computer system controls for quality and production records, inadequate laboratory sampling plans for the water system, and insufficient control and reconciliation of master production and control records. These issues indicate a lack of robust data integrity and quality control practices.