FDA 483 - General Physiotherapy Inc - July 01, 2022

General Physiotherapy Inc, a medical device manufacturer in Earth City, MO, received a Form FDA-483 for multiple deficiencies in its quality system. The inspection revealed a lack of adequately established procedures and documented evidence for critical activities including acceptance, device history records, servicing, purchasing, labeling, and document control. These observations indicate a systemic failure to maintain a compliant quality management system.