Sharp Sterile Manufacturing, 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
- 480 Pleasant Street, Lee, Massachusetts (MA) 01238, United States (USA)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3012144557 · DUNS 079589218
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 3 drugs, 1 already in shortage. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2026-03-05
- VAIHuman Cellular, Tissue, and Gene Therapies2024-06-12
- VAIDrug Quality Assurance2023-08-25
- VAIBlood and Blood Products2023-01-20
- VAIDrug Quality Assurance2021-10-15
- OAIDrug Quality Assurance2020-10-27
Drugs this plant is listed as making
3 distinct drugs across 3 products name this site in their FDA label.
- Apomorphine HydrochlorideTruPharma, LLC
- furosemidein shortageSQ Innovation, Inc.
- Sodium ThiosulfateFennec Pharmaceuticals 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.