FDA 483 - General Physiotherapy Inc - March 12, 2025

An FDA inspection of General Physiotherapy II LLC in Saint Charles, MO, a manufacturer of medical devices, revealed significant quality system deficiencies. The firm was cited for failing to implement unique device identifier (UDI) labeling, perform quality audits, establish device history record procedures, and adequately maintain complaint files. Additionally, the firm lacked a quality agreement with its primary supplier, with some observations noted as repeats from previous inspections.