Biogen MA Inc.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 5000 Davis Drive, Morrisville, North Carolina (NC) 27560, United States (USA)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3000719749 · DUNS 841087823
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBlood and Blood Products2024-07-12
- VAIBlood and Blood Products2019-02-15
- NAIDrug Quality Assurance2018-06-13
- VAIBlood and Blood Products2017-03-23
- NAIDrug Quality Assurance2016-01-15
- NAIDrug Quality Assurance2015-06-19
- VAIDrug Quality Assurance2014-11-14
- NAIBioresearch Monitoring2013-08-02
- VAIDrug Quality Assurance2013-08-02
- VAIDrug Quality Assurance2011-09-30
- NAIDrug Quality Assurance2009-09-25
- NAIBioresearch Monitoring2009-01-29
Drugs this plant is listed as making
7 distinct drugs across 16 products name this site in their FDA label.
- Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtlBioverativ Therapeutics Inc.
- DaratumumabJanssen Biotech, Inc.
- guselkumabJanssen Biotech, Inc.
- talquetamabJanssen Biotech, Inc.
- teclistamab-cqyvJanssen Biotech, Inc.
- TocilizumabBiogen MA Inc
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.