# FDA 483 - Vivex Biologics, Inc. - August 04, 2022

Source: https://www.keypedia.com/records/483/vivex-biologics-inc/af689f42-0c7e-4eee-bd15-92dad40cf41a

> FDA 483 for Vivex Biologics, Inc. on August 04, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vivex Biologics, Inc.
- Inspection Date: 2022-08-04
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Vivex Biologics, Inc. in Miami, FL, a tissue processor, revealed that facilities were not maintained in a good state of repair. Specifically, electrical outlets in ISO-5 cleanroom processing areas showed extensive corrosion, rust buildup, and chipping paint. These conditions were observed in rooms used for processing HCT/P bone products, indicating potential issues with environmental control and product integrity.

## Related Documents

- [483 - 2015-12-18](https://www.keypedia.com/records/483/vivex-biologics-inc/4b8c7277-5546-4b80-9814-dc05babfa071)
- [483 - 2017-07-06](https://www.keypedia.com/records/483/vivex-biologics-inc/55033044-bbaf-44a0-be9c-157bbd2da375)

## Related Officers

- [Lura Baquero](https://www.keypedia.com/people/lura-baquero/55dc6eb5-01d5-427e-a3ef-cc6ca35f3837)
- [Sergio E. Delgado](https://www.keypedia.com/people/sergio-e-delgado/5edfee62-05aa-44aa-9161-def8f31d3ea2)
- [Christopher J. Adams](https://www.keypedia.com/people/christopher-j-adams/f7010846-7fd1-4ee8-901a-1015656fea0a)

Company: https://www.keypedia.com/companies/vivex-biologics-inc/53889265-7ee0-41bd-964a-e596f7a588e8

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