InVia Fertility Specialists, PLLCFebruary 5, 2025

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore InVia Fertility Specialists, PLLC

Record Details

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.

Company: InVia Fertility Specialists, PLLC
Inspection Date: February 5, 2025
Product Type: Biologics
Office: Chicago District Office
Person: Zoey A. Trombley (FDA_PERSONNEL)

Open in Dashboard

ID · 6c877623-5855-4f05-8042-29296ed3ec92