# FDA 483 - Apolo - Megasun LLC - August 29, 2024

Source: https://www.globalkeysolutions.net/records/483/apolo-megasun-llc/9218d35a-af7e-4ef6-a323-5880f7198578

> FDA 483 for Apolo - Megasun LLC on August 29, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apolo - Megasun LLC
- Inspection Date: 2024-08-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Apolo - Megasun LLC, a manufacturer of photobiomodulation tables/beds in Saint Louis, MO, was cited for significant quality system deficiencies. Observations included inadequate finished device acceptance procedures, lack of unique device identifier (UDI) labeling, insufficient equipment calibration records, and a complete absence of design control procedures for their Class II medical devices. These issues indicate a broad failure to adhere to medical device quality system regulations.

## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/apolo-megasun-llc/bf343ac9-1d97-4c5e-8236-2af69356397f

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8