Center for Human ReproductionJuly 20, 2022

FDA 483 - Center for Human Reproduction - July 20, 2022

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 Center for Human Reproduction

Record Details

Northwell Health Fertility in Manhasset, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in the screening and eligibility determination processes for HCT/P oocyte donors, including inadequate Zika Virus screening and untimely medical record reviews. Furthermore, the firm lacked established procedures for determining donor eligibility.

Company: Center for Human Reproduction
Inspection Date: July 20, 2022
Product Type: Other
Office: Philadelphia District Office
Person: Irina Gaberman (Investigator)

Open in Dashboard

ID · 43086d89-7db0-4f14-88b8-9f13d10c6ef7