# FDA 483 - Love Rehab Solutions Inc - December 17, 2019

Source: https://www.keypedia.com/records/483/love-rehab-solutions-inc/cc70a817-959c-4d7d-804e-15e27a8a4939

> FDA 483 for Love Rehab Solutions Inc on December 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Love Rehab Solutions Inc
- Inspection Date: 2019-12-17
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Love Rehab Solutions, a medical device manufacturer in Oxford, GA, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, including a lack of established procedures for various critical functions like complaint handling, MDRs, CAPA, design control, process control, and acceptance activities. Additionally, the firm failed to establish and maintain essential device documentation such as the design history file, device master record, and device history records for their safety beds.

## Related Officers

- [Miaja Umaedi](https://www.keypedia.com/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)

Company: https://www.keypedia.com/companies/love-rehab-solutions-inc/8e794195-ef81-48d1-974c-bd1e7b683a07

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7