Sharp Clinical Services, 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
- 2400 Baglyos Circle, Bethlehem, Pennsylvania (PA) 18020, United States (USA)
- Operations here
- analysislabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3003673570 · DUNS 079209266
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2024-08-29
- VAIDrug Quality Assurance2022-09-02
- VAIDrug Quality Assurance2019-08-30
- NAIDrug Quality Assurance2015-08-27
- NAIDrug Quality Assurance2012-04-20
- VAIDrug Quality Assurance2009-04-14
Drugs this plant is listed as making
3 distinct drugs across 8 products name this site in their FDA label.
- Elamipretide HydrochlorideStealth Biotherapeutics Inc.
- sirolimusNobelpharma America, LLC
- sodium phenylbutyrateAcer Therapeutics 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.