Charles River Laboratories, 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
- 358 Technology Drive, Malvern, Pennsylvania (PA) 19355, United States (USA)
- Operations here
- analysis
- FDA identifiers
- FEI 1000121235 · DUNS 078495006
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2026-01-20
- VAIDrug Quality Assurance2024-01-04
- NAIDrug Quality Assurance2019-01-17
- NAIDrug Quality Assurance2015-04-20
- NAIDrug Quality Assurance2012-03-15
- NAIDrug Quality Assurance2010-01-08
Drugs this plant is listed as making
4 distinct drugs across 4 products name this site in their FDA label.
- anakinraSwedish Orphan Biovitrum AB (publ)
- ImigluceraseGenzyme Corporation
- SiltuximabRecordati Rare Diseases, 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.