American Contract Systems Inc. – FDA 483, Sep 24, 2021

An FDA inspection of American Contract Systems Inc. in Grimes, IA, a contract sterilizer and manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for handling nonconforming product, insufficient process controls for gas injection sterilization, and a lack of equipment maintenance logs. Additionally, the firm failed to establish proper controls for labeling activities, indicating a broad pattern of procedural shortcomings.