# FDA 483 - Redicare LLC - January 10, 2025

Source: https://www.globalkeysolutions.net/records/483/redicare-llc/8f9398e5-79e7-4edd-bae7-1c87b281a7d1

> FDA 483 for Redicare LLC on January 10, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Redicare LLC
- Inspection Date: 2025-01-10
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Redicare LLC, a medical device manufacturer and importer in Congers, NY, revealed a significant compliance issue. The firm failed to maintain written Medical Device Reporting (MDR) procedures and did not register for the FDA's Electronic Submissions Gateway (ESG) system. This indicates a critical deficiency in their system for reporting serious adverse events related to medical devices.

## Related Documents

- [483 - 2022-03-25](https://www.globalkeysolutions.net/records/483/redicare-llc/5d4d03e5-1a1e-4b33-a78c-cf6b858b9ebf)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

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

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d