FDA Warning Letter — Magellan Diagnostics, Inc.

Case 532743 — FEI 1218996

The FDA took a Warning Letter action against Magellan Diagnostics, Inc. on October 23, 2017 (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
October 23, 2017
Fiscal Year
2018
Product Type
Devices
Center
CDRH
Location
North Billerica, MA (United States)