483
Huntington Reproductive Center Medical GroupFDA 483 - Huntington Reproductive Center Medical Group - October 29, 2024
Discuss this record with AI
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.
Record Details
An FDA inspection of Huntington Reproductive Center Medical Group in Newport Beach, CA, identified two significant observations concerning their HCT/P operations. The firm failed to properly determine donor eligibility based on screening questionnaires, specifically regarding a donor's travel history. Additionally, personal identifying information, such as dates of birth, was found on accompanying records for anonymous oocyte donors.
- Inspection Date
- October 29, 2024
- Product Type
- Biologics
- Person
Open in Dashboard
ID · 12919cce-d37a-4a7e-a206-1ecca9544d86