Societal CDMO Gainesville, 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
- 1300 Gould Drive, Gainesville, Georgia (GA) 30504, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 1035761 · DUNS 057585150
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-11-19
- VAIDrug Quality Assurance2018-01-24
- NAIDrug Quality Assurance2017-01-31
- NAIDrug Quality Assurance2014-03-18
- NAIDrug Quality Assurance2011-11-17
- NAIDrug Quality Assurance2010-12-21
- NAIDrug Quality Assurance2010-03-24
Drugs this plant is listed as making
0 distinct drugs across 0 products name this site in their FDA label.
No drug labels currently list this site.
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.