Biogen MA Inc.

FDA Regulatory Profile

Biogen MA Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 12 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0148-2021, Class II) was initiated on December 9, 2020.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
12
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0148-2021Class IIVumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)1December 9, 2020
D-1381-2020Class IIITecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, ManufacturJune 23, 2020