# FDA 483 - InVia Fertility Specialists, PLLC - February 05, 2025

Source: https://www.globalkeysolutions.net/records/483/invia-fertility-specialists-pllc/6c877623-5855-4f05-8042-29296ed3ec92

> FDA 483 for InVia Fertility Specialists, PLLC on February 05, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InVia Fertility Specialists, PLLC
- Inspection Date: 2025-02-05
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of InVia Fertility Specialists, PLLC in Hoffman Estates, IL, revealed multiple deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to adequately screen and test donors for communicable diseases, maintain proper documentation for donor eligibility, and correctly label and quarantine HCT/Ps from ineligible donors. This inspection also noted a repeat violation regarding the lack of established procedures for donor testing and screening.

## Related Documents

- [483 - 2022-09-09](https://www.globalkeysolutions.net/records/483/invia-fertility-specialists-pllc/cafc0b3c-9b24-43fc-8cca-40f0c6d82198)
- [WARNING_LETTER - 2025-02-05](https://www.globalkeysolutions.net/records/warning_letter/invia-fertility-specialists-pllc/37e0e7e2-df7f-4564-ab6e-614b9d9f4e7e)

## Related Officers

- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/zoey-a-trombley/cb7ac4dd-bc47-4b51-8fef-a485b122c921)

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

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