Phoenix Thera-Lase Systems LLC – FDA 483, Jun 3, 2024

During an inspection conducted from May 22 to June 3, 2024, the FDA issued a Form 483 to Phoenix Thera-Lase Systems LLC, a medical device specification developer. The inspection revealed 18 significant observations primarily concerning the company's failure to establish and adequately maintain a robust quality system, as required for medical device manufacturers and distributors. Key violations included a widespread absence of documented procedures and records across critical areas such as design controls, including design transfer, review, validation, and design history files for their Class IV Phoenix Thera-Lase Laser System. The firm also lacked proper procedures for medical device reporting, control of nonconforming products, corrective and preventive actions, complaint handling, and process controls for their repackaging and relabeling operations. Furthermore, the company demonstrated deficiencies in essential quality management system elements, including quality audits, management review, and training. Regarding their laser products, the company failed to provide documentation for laser certification, lacked quality control procedures for radiation safety, and exhibited multiple labeling issues, including missing certification and identification labels, and an incorrect DANGER logotype. Additionally, Phoenix Thera-Lase Systems LLC had not submitted required product reports to the FDA nor registered their Class IV laser system in the Global Unique Device Identification Database (GUDID), failing to apply a Unique Device Identifier (UDI) to product labels. These observations indicate a systemic lack of adherence to medical device quality system regulations and electronic product radiation safety standards. Phoenix Thera-Lase Systems LLC is required to implement comprehensive corrective actions to address these deficiencies and ensure full compliance with regulatory requirements.