Columbia University Fertility CenterJuly 23, 2019

FDA 483 - Columbia University Fertility Center - July 23, 2019

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 Columbia University Fertility Center

Record Details

An FDA inspection of Columbia University Fertility Center identified a significant lapse in donor screening practices. The facility deemed an oocyte donor eligible despite her having risk factors for Zika virus infection. This resulted in the donation and subsequent use or cryopreservation of oocytes from a potentially at-risk donor.

Company: Columbia University Fertility Center
Inspection Date: July 23, 2019
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East I
Person: Irina Gaberman (Investigator)

Open in Dashboard

ID · 4e591f2b-44be-4395-99c1-0b5573c0df0b