W. R. Grace & Co.-Conn.
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
- 1421 Kalamazoo St, South Haven, Michigan (MI) 49090-1945, United States (USA)
- Operations here
- api manufacture
- FDA identifiers
- FEI 1826582 · DUNS 788779192
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2026-03-02
- NAIDrug Quality Assurance2017-12-08
- NAIDrug Quality Assurance2014-05-14
- NAIDrug Quality Assurance2012-01-19
- NAIDrug Quality Assurance2010-11-19
- NAIDrug Quality Assurance2009-07-22
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- hydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.
- LarotrectinibLoxo Oncology, 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.