# FDA 483 - Toyo Medical Co. - January 31, 2020

Source: https://www.globalkeysolutions.net/records/483/toyo-medical-co/abd6a481-d0a8-4f49-8b1d-d6024ed8529b

> FDA 483 for Toyo Medical Co. on January 31, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Toyo Medical Co.
- Inspection Date: 2020-01-31
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Toyo Medical Co. in Doral, FL, an importer/exporter/dealer/distributor of medical devices, revealed significant deficiencies in its quality system. The firm failed to establish written procedures for Medical Device Reporting (MDR), complaint handling, and corrective and preventive actions (CAPA). These omissions indicate a fundamental lack of control over critical quality processes.

## Related Officers

- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.globalkeysolutions.net/companies/toyo-medical-co/81938c80-08b9-4663-9b00-a00f2cbfa43a

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6