Bioreliance Corporation
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
- 9820 Darnestown Road, Rockville, Maryland (MD) 20850, United States (USA)
- Operations here
- analysis
- FDA identifiers
- FEI 1122041 · DUNS 119271065
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIBioresearch Monitoring2026-01-29
- VAIVaccines and Allergenic Products2024-11-22
- NAIDrug Quality Assurance2023-08-04
- VAIDrug Quality Assurance2018-07-13
- VAIVaccines and Allergenic Products2018-07-13
- NAIDrug Quality Assurance2016-01-11
- VAIDrug Quality Assurance2014-05-14
- VAIVaccines and Allergenic Products2013-08-29
- VAIDrug Quality Assurance2012-07-03
- VAIVaccines and Allergenic Products2010-10-28
- NAIHuman Cellular, Tissue, and Gene Therapies2010-03-17
- VAIDrug Quality Assurance2009-02-18
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- nipocalimab-aahuJanssen Biotech, Inc.
- zopapogene imadenovecPrecigen, 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.