FDA 483 - Maitland Engineering. Inc. - October 15, 2021

Maitland Engineering, Inc. in South Bend, IN, a medical device manufacturer, was cited for inadequate corrective and preventive action (CAPA) procedures. The firm failed to properly classify and initiate CAPAs for recurring nonconforming products, specifically screws, despite multiple Nonconformance Reports (NCRs) identifying similar defects. This indicates a systemic issue in addressing product quality problems.