# FDA 483 - Redicare LLC - March 25, 2022

Source: https://www.keypedia.com/records/483/redicare-llc/5d4d03e5-1a1e-4b33-a78c-cf6b858b9ebf

> FDA 483 for Redicare LLC on March 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Redicare LLC
- Inspection Date: 2022-03-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Redicare llc, a manufacturer of medical devices, was inspected by the FDA and cited for significant deficiencies in its quality system. The firm failed to establish adequate procedures for receiving, reviewing, and evaluating complaints, including investigating complaints for its Body Fluid Cleanup Kit and First Aid Kit and determining the necessity of Medical Device Reports. Additionally, Redicare llc lacked established procedures for corrective and preventive actions.

## Related Documents

- [483 - 2025-01-10](https://www.keypedia.com/records/483/redicare-llc/8f9398e5-79e7-4edd-bae7-1c87b281a7d1)

## Related Officers

- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/redicare-llc/65c7593c-6b75-49c8-ab6b-4008ec78f70f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961