FDA 483 - Life Science Outsourcing, Inc. - April 21, 2017

Life Science Outsourcing, Inc. in Brea, CA, a contract sterilizer, received a Form 483 with six observations during an inspection from April 19-21, 2017. The observations primarily concern deficiencies in written procedures, employee training and qualifications, and equipment qualification and calibration, particularly related to biological indicator testing and laminar flow hoods. These issues indicate a lack of adequate controls to ensure the quality and sterility of drug products.