# FDA 483 - Viera Fertility Center - February 03, 2023

Source: https://www.keypedia.com/records/483/viera-fertility-center/50adef31-4653-4481-9afe-2fe5692caf8b

> FDA 483 for Viera Fertility Center on February 03, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Viera Fertility Center
- Inspection Date: 2023-02-03
- Product Type: biologics
- Office Name: Office of Compliance Intervention and Consultation
- Summary: The Food and Drug Administration (FDA) conducted an inspection of Viera Fertility Center, a reproductive establishment, from February 2-3, 2023. The inspection resulted in the issuance of an FDA Form 483, detailing an observation of objectionable conditions or practices. The primary issue identified was that the facility's donor screening process failed to adequately screen for risk factors associated with communicable disease agents and diseases. Specifically, the firm's donor screening questionnaire was found deficient as it did not include questions to identify individuals who had sexual contact within the preceding six months with a person diagnosed with Zika Virus (ZIKV), or with a person residing in or having traveled to an area with an elevated risk for ZIKV transmission during that same period. This observation highlights a need for the Viera Fertility Center to enhance its donor screening protocols to align with regulatory expectations for preventing the transmission of communicable diseases. While the FDA Form 483 itself is an observation report, it necessitates a response from the firm. Viera Fertility Center is expected to discuss any objections or submit plans for corrective actions to address this identified deficiency, ensuring compliance with relevant sections of the Federal Food, Drug and Cosmetic Act.

## Related Documents

- [483 - 2019-06-05](https://www.keypedia.com/records/483/viera-fertility-center/950d1377-077b-4d27-aca4-0966fa9ac4f2)
- [483 - 2023-02-03](https://www.keypedia.com/records/483/viera-fertility-center/714d443f-fdbe-4c7b-92de-9abb8c12ec10)

## Related Officers

- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)

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

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54