# FDA 483 - Vivex Biologics, Inc. - July 06, 2017

Source: https://www.globalkeysolutions.net/records/483/vivex-biologics-inc/55033044-bbaf-44a0-be9c-157bbd2da375

> FDA 483 for Vivex Biologics, Inc. on July 06, 2017. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vivex Biologics, Inc.
- Inspection Date: 2017-07-06
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Osiris Biomedical, Inc. in Miami, FL, an HCTP manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a lack of validation for their disinfection process, inadequate investigations into numerous positive post-processing cultures, and processing HCT/Ps without proper disinfection. Additionally, the firm failed to maintain equipment cleanliness, with rusted carts found in clean processing rooms.

## Related Documents

- [483 - 2015-12-18](https://www.globalkeysolutions.net/records/483/vivex-biologics-inc/4b8c7277-5546-4b80-9814-dc05babfa071)
- [483 - 2022-08-04](https://www.globalkeysolutions.net/records/483/vivex-biologics-inc/af689f42-0c7e-4eee-bd15-92dad40cf41a)

## Related Officers

- [Ivan E. Reyes](https://www.globalkeysolutions.net/people/ivan-e-reyes/69bac3eb-f63c-45f0-8420-85a7e06b884a)
- [issuing_officer](https://www.globalkeysolutions.net/people/shavon-l-square/6a15df34-1af6-44f7-8874-c8606691f7e0)
- [Colleen Aspinwall](https://www.globalkeysolutions.net/people/colleen-aspinwall/d3c98644-e796-4a7f-82d0-9c49e93c0940)

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

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