FDA Warning Letter — Gentuity, LLC

Case 731931 — FEI 3011578544

The FDA took a Warning Letter action against Gentuity, LLC on July 2, 2026 (Sudbury, MA). The action was issued by CDRH and concerns devices products. This facility has 2 recent FDA inspections on record.

Action Details

Facility
Gentuity, LLC
Date
July 2, 2026
Fiscal Year
2026
Product Type
Devices
Center
CDRH
Location
Sudbury, MA (United States)