# FDA 483 - InVia Fertility Specialists, PLLC - September 09, 2022

Source: https://www.keypedia.com/records/483/invia-fertility-specialists-pllc/cafc0b3c-9b24-43fc-8cca-40f0c6d82198

> FDA 483 for InVia Fertility Specialists, PLLC on September 09, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InVia Fertility Specialists, PLLC
- Inspection Date: 2022-09-09
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: InVia Fertility Specialists, PLLC, a reproductive tissue establishment in Hoffman Estates, IL, was cited for multiple deficiencies related to donor eligibility and communicable disease screening during an FDA inspection. Observations included failures to test oocyte donors for relevant communicable disease agents like West Nile Virus, inadequate screening for risk factors, and incomplete standard operating procedures for donor eligibility determination. These issues indicate a significant lapse in ensuring the safety of reproductive tissues.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/paul-m-chefor/96bea4a8-b1ee-4870-ae8b-24794c67da21)

Company: https://www.keypedia.com/companies/invia-fertility-specialists-pllc/4877cf5a-886e-4503-9076-3382aeafab41

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669