FDA 483 - Pajunk Medical Systems, L.P. - March 18, 2022

Pajunk Medical Systems, L.P. in Alpharetta, GA, was inspected by the FDA, revealing significant deficiencies across its quality system. The inspection identified a pervasive lack of established and adequately documented procedures for critical processes such as sterilization validation, nonconformance control, CAPA, design change, complaint handling, management review, quality audits, document control, device history records, and purchasing controls. These findings indicate a broad breakdown in the firm's quality management, suggesting a high level of non-compliance.