Phillips Precision, Inc. – FDA 483, Jul 17, 2024

An FDA inspection of Phillips Precision, Inc., a contract manufacturer, conducted from April 22 to July 17, 2024, revealed significant deficiencies in its Quality System, particularly regarding cleaning processes for implantable devices and surgical instruments, and its corrective and preventive action (CAPA) system. The main violations centered on inadequate validation of critical cleaning processes. Phillips Precision failed to conduct comprehensive risk assessments, perform essential testing like cytotoxicity and endotoxin, and adequately challenge worst-case manufacturing conditions or load configurations. Unvalidated supplementary cleaning methods and insufficient sampling plans further compounded these issues. Monitoring and control of validated process parameters were also deficient. The company lacked procedures for load weight monitoring, experienced insufficient temperature controls, and failed to address out-of-specification start-up temperatures, which affected thousands of devices, including implants, without proper nonconformance reporting. Preventive maintenance for detergent concentration was less frequent than recommended by equipment specifications. Phillips Precision's CAPA system proved inadequate in effectively identifying and addressing root causes of nonconforming products. Investigations into issues like product staining and metal debris were found to be incomplete, failing to trend nonconformances across product lines, consider all potential causes (e.g., cleaning machine revalidation), or verify corrective actions over sufficient periods. The CAPA threshold system itself was also deemed flawed, not adequately considering risk or in-process nonconformances. Operating under the medical device Good Manufacturing Practices (21 CFR Part 820), Phillips Precision is required to implement comprehensive corrective actions. This involves revalidating deficient processes, establishing rigorous monitoring and control procedures, enhancing the CAPA system for thorough investigation and effective verification, and ensuring all quality system procedures meet regulatory standards to safeguard product safety and quality.