FDA 483 - Photonic Health, LLC - May 17, 2019

PHONONIC HEALTH, LLC, a medical device specification developer in Ocala, FL, was cited for numerous quality system deficiencies during an FDA inspection. The observations primarily concern inadequate procedures and documentation related to design controls, purchasing, acceptance activities, corrective and preventive actions, complaint handling, and quality audits. The firm also lacked documented design risk analysis and written Medical Device Reporting (MDR) procedures.