FDA Warning Letter — ProDx Health

Case 720762 — FEI 3042120427

The FDA took a Warning Letter action against ProDx Health on January 8, 2026 (Menlo Park, CA). The action was issued by CBER and concerns biologics products.

Action Details

Facility
ProDx Health
Date
January 8, 2026
Fiscal Year
2026
Product Type
Biologics
Center
CBER
Location
Menlo Park, CA (United States)