FDA 483 - Phoenix Thera-Lase Systems LLC - June 03, 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 regarding the company's compliance with medical device quality system regulations and electronic product radiation control standards for their Class IV Therapeutic Laser Systems. Major deficiencies included a severe lack of established and adequately implemented procedures across fundamental quality system elements. Specifically, the company failed to establish proper design controls, with critical design history files for their laser system being unavailable. Procedures for managing medical device reports, controlling nonconforming products, and implementing corrective and preventive actions were either absent or inadequate. Furthermore, Phoenix Thera-Lase Systems LLC exhibited non-compliance with laser product-specific regulations. They could not provide documentation for laser product certification or quality control procedures for radiation safety. The Class IV laser systems lacked required certification and identification labels, and the DANGER logotype on labeling was non-compliant. The company also failed to submit necessary product reports to the FDA. Finally, the firm did not meet Unique Device Identification (UDI) requirements, failing to register their laser system in the GUDID database or include UDI on product labels. Addressing these widespread issues requires immediate and comprehensive corrective actions to ensure regulatory compliance and product safety.