# FDA 483 - Viera Fertility Center - June 05, 2019

Source: https://www.globalkeysolutions.net/records/483/viera-fertility-center/950d1377-077b-4d27-aca4-0966fa9ac4f2

> FDA 483 for Viera Fertility Center on June 05, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viera Fertility Center
- Inspection Date: 2019-06-05
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Viera Fertility Center in Melbourne, FL, revealed a significant deficiency in their documentation practices. The firm failed to adequately document procedures for testing, screening, and determining donor eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This issue specifically impacts their processes for anonymous and directed egg and sperm donors.

## Related Documents

- [483 - 2023-02-03](https://www.globalkeysolutions.net/records/483/viera-fertility-center/714d443f-fdbe-4c7b-92de-9abb8c12ec10)

## Related Officers

- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.globalkeysolutions.net/companies/viera-fertility-center/25b4c965-5aa9-48d7-803f-c9575927063b

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