FDA 483 - Photonic Health, LLC - March 24, 2022

Photonic Health, LLC, a medical device manufacturer in Ocala, FL, was inspected by the FDA from March 21-24, 2022. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design change, design validation, risk analysis, supplier management, acceptance activities, corrective and preventive actions, quality audits, and medical device reporting. Many of these issues were previously cited in a 2019 inspection and a 2020 letter, indicating a persistent lack of compliance.