FDA 483 - Technicuff Corp. - April 24, 2024

Technicuff Corp. in Leesburg, FL, a medical device manufacturer, was inspected by the FDA from April 22-24, 2024. The inspection revealed five observations related to inadequate quality system procedures, including issues with nonconforming product control, statistical techniques for product acceptance, management representation, document control, and purchasing controls. Several violations were noted as repeat issues, indicating significant deficiencies in their quality management system.