FDA 483 - Pontis Orthopaedics, LLC - July 05, 2018

Pontis Orthopaedics, LLC, a medical device manufacturer in San Francisco, CA, was inspected and received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies across its quality system, including inadequate sterilization validation, ineffective CAPA processes, insufficient risk analysis, and poor control of nonconforming products. Additionally, the firm failed to properly qualify consultants, conduct regular quality audits and management reviews, and maintain essential quality system records.