# FDA 483 - Nyx Inc. - November 17, 2023

Source: https://www.keypedia.com/records/483/nyx-inc/229c72b8-6378-4dcd-a3a7-9b47eb91e7d3

> FDA 483 for Nyx Inc. on November 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nyx Inc.
- Inspection Date: 2023-11-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Nyx Inc. in San Juan, PR, a manufacturer of medical devices, revealed significant deficiencies across its quality system. The firm failed to establish fundamental procedures for organizational structure, design control, corrective and preventive actions, complaint handling, and purchasing controls. These issues indicate a severe lack of adherence to current good manufacturing practices for medical devices.

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/nyx-inc/97dabfbb-9440-4b78-bfdf-3e8fb06c54dc

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6