FDA 483 - American Contract Systems, Inc. - August 16, 2019

American Contract Systems, Inc. in Tampa, FL, a medical device manufacturer, received a Form FDA 483 with eight observations following an inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate sterilization and software validation, insufficient design controls, and failures in purchasing controls, complaint handling, and CAPA procedures. These issues indicate a systemic lack of established and followed procedures critical for ensuring product quality and safety.