FDA 483 - American Contract Systems, Inc. - October 04, 2019

The FDA inspected American Contract Systems, Inc. in Houston, TX, and found significant deficiencies in their sterilization process validation and control. The firm failed to adequately validate its sterilization processes, monitor critical parameters, revalidate processes after changes, and maintain complete device master records. These issues led to potential sterility assurance problems and product quality concerns, including multiple complaints of foreign matter in sterilized surgical packs.