# FDA 483 - Red Medical Solutions, Inc. - March 22, 2023

Source: https://www.globalkeysolutions.net/records/483/red-medical-solutions-inc/e0d2809a-8e81-4c4e-99ca-5fd2c76f9bc9

> FDA 483 for Red Medical Solutions, Inc. on March 22, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Red Medical Solutions, Inc.
- Inspection Date: 2023-03-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Red Medical Solutions, Inc., a medical device importer and exporter in Patchogue, NY, revealed significant deficiencies in their quality system. The firm failed to establish procedures for receiving, reviewing, and evaluating customer complaints. Additionally, the company lacked established procedures for corrective and preventive actions, particularly concerning investigations into non-conforming devices.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/red-medical-solutions-inc/6d271884-ac0f-483e-8236-b5f11a28d819

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