FDA Warning Letter — Magellan Diagnostics, Inc.
The FDA took a Warning Letter action against Magellan Diagnostics, Inc. on Dec 23, 2025 (North Billerica, MA). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.
Action Details
- Facility
- Magellan Diagnostics, Inc.
- Date
- Dec 23, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Center
- CDRH
- Location
- North Billerica, MA (United States)