FDA 483 - American Contract Systems, Inc. - April 08, 2022

An FDA inspection of American Contract Systems, Inc. in Temple Terrace, FL, revealed significant deficiencies in their quality system for manufacturing sterile surgical kits. The firm was cited for inadequate process validation for sterilization, a repeat observation for lacking design control procedures, and repeated issues with their corrective and preventive action system. Additionally, the inspection found failures in establishing and documenting employee training.