Body Balance System LLCSeptember 29, 2022

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

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Record Details

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.

Company: Body Balance System LLC
Inspection Date: September 29, 2022
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Charles L. Larson (investigator)

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ID · 08ce028a-916a-4977-83d4-c4a80f783621