FDA 483 - Body Balance System LLC - September 29, 2022

Body Balance System, a medical device manufacturer in Las Vegas, was cited for multiple deficiencies during an FDA inspection regarding their OvationULT Red Light Therapy Beds. The firm lacked established procedures for handling complaints, performing servicing activities, and ensuring proper training for production activities. Additionally, the firm failed to establish Unique Device Identifier (UDI) labeling for its product.