# FDA 483 - Sleepsafe Beds, LLC - October 19, 2023

Source: https://www.globalkeysolutions.net/records/483/sleepsafe-beds-llc/91a6badf-747b-44b6-954b-d38311434ad9

> FDA 483 for Sleepsafe Beds, LLC on October 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sleepsafe Beds, LLC
- Inspection Date: 2023-10-19
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Sleepsafe Beds, LLC in Bassett, VA, a manufacturer of beds, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for acceptance activities, corrective and preventive actions (CAPA), and control of nonconforming products. Additionally, software used in production was not adequately validated, indicating a broad lack of adherence to quality system requirements.

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/sleepsafe-beds-llc/7674c61d-a5c3-4ef7-90ea-d64fd4007877

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64