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Manufacturing facility

Cosette Pharmaceuticals NC 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
1877 Kawai Road, Lincolnton, North Carolina (NC) 28092, United States (USA)
Operations here
analysislabelmanufacturepack
FDA identifiers
FEI 1053439 · DUNS 079419931

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • VAIDrug Quality Assurance2023-07-21
  • NAIDrug Quality Assurance2017-11-30
  • NAIDrug Quality Assurance2016-07-29
  • NAIDrug Quality Assurance2014-02-24
  • NAIDrug Quality Assurance2012-09-25
  • NAIDrug Quality Assurance2011-03-04

Drugs this plant is listed as making

38 distinct drugs across 58 products name this site in their FDA label.

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.