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

Source: https://www.globalkeysolutions.net/records/483/body-balance-system-llc/08ce028a-916a-4977-83d4-c4a80f783621

> FDA 483 for Body Balance System LLC on September 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Body Balance System LLC
- Inspection Date: 2022-09-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/body-balance-system-llc/85958808-871f-45f6-a737-9c40d850bd9d

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6