# FDA 483 - Genesiscare - February 25, 2020

Source: https://www.globalkeysolutions.net/records/483/genesiscare/62cc8568-2f31-4766-a7c0-f6c9f4160789

> FDA 483 for Genesiscare on February 25, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genesiscare
- Inspection Date: 2020-02-25
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 21st Century Oncology, Inc. in Naples, FL, a blood irradiation establishment, received a Form 483 with two observations. The inspection revealed significant issues with recordkeeping for blood and blood component irradiation processes, including undocumented verification steps and recurrent deficiencies in log entries. Additionally, the firm failed to consistently follow its own written standard operating procedures for blood irradiation documentation.

## Related Officers

- [Annette Melendez](https://www.globalkeysolutions.net/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

Company: https://www.globalkeysolutions.net/companies/genesiscare/14d2d975-d3f3-4d79-899f-46e57baef12e

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