FDA 483 - PADCO HOLDING COMPANY, LLC - October 24, 2025

PADCO HOLDING COMPANY, LLC in Newbury, OH, was inspected and cited for multiple quality system deficiencies related to the manufacturing of Class II medical devices. Key issues include a lack of process validation, inadequate procedures for rework and purchasing, and insufficient documentation for device history records, corrective actions, and employee training. These observations indicate significant gaps in the firm's quality management system.