# FDA 483 - Beds by George - December 02, 2021

Source: https://www.keypedia.com/records/483/beds-by-george/f993a09e-7bba-4140-aab0-69935880a00c

> FDA 483 for Beds by George on December 02, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beds by George
- Inspection Date: 2021-12-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Beds by George, a manufacturer of semi-electric beds, was inspected by the FDA from November 30 to December 2, 2021. The inspection revealed a significant repeat observation regarding the firm's design history file, specifically failures in design verification and validation for their medical devices. This indicates a serious lapse in quality system requirements for medical device design controls.

## Related Documents

- [483 - 2019-08-15](https://www.keypedia.com/records/483/beds-by-george/dab3a526-9bf5-469c-920b-c4906f74220a)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/beds-by-george/8ac02c54-d86c-4ae6-9c2b-04819f04b68d

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0