FDA 483 - Photonicare Inc - August 25, 2023

Photonicare Inc, a medical device manufacturer in Champaign, IL, received a Form FDA 483 citing three observations related to its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, including issues with CAPA effectiveness verification and software updates. Additionally, the firm's design change procedures lacked defined categories, and management failed to ensure the quality policy was understood by employees and contained misleading information.