Bionique Testing Laboratories LLC
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
- 156 Fay Brook Drive, Saranac Lake, New York (NY) 12983-5802, United States (USA)
- Operations here
- analysis
- FDA identifiers
- FEI 1318709 · DUNS 108684523
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2026-01-15
- NAIHuman Cellular, Tissue, and Gene Therapies2025-10-20
- NAIDrug Quality Assurance2020-09-04
- NAIDrug Quality Assurance2015-04-22
- VAIDrug Quality Assurance2012-07-26
- NAIDrug Quality Assurance2010-02-03
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- olipudase alfa-rpcpGenzyme Corporation
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.