# FDA 483 - Genicon, Inc. - January 17, 2020

Source: https://www.keypedia.com/records/483/genicon-inc/10af1db0-3f6e-4897-a356-5ab5423e11db

> FDA 483 for Genicon, Inc. on January 17, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genicon, Inc.
- Inspection Date: 2020-01-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Genicon, Inc. received a Form 483 citing 15 observations related to significant deficiencies in its quality system for medical devices. Issues include inadequate organizational structure, complaint handling, purchasing controls, MDR reporting, CAPA, design controls, and sterilization validation. These deficiencies indicate a systemic breakdown in ensuring device safety and efficacy.

## Related Officers

- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.keypedia.com/companies/genicon-inc/7e685742-7b88-4c86-911e-89869cc5e559

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