Societal Cdmo Gainesville
United States Updated 9 July 2026
Societal Cdmo Gainesville is a finished-dose manufacturer based in United States. It appears in 3 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY) and FDA (GH). Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 19 November 2024 as VAI.
2
registered plants
1 with an FDA FEI number
3
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 19 November 2024 VAI US FDA
- 24 January 2018 VAI US FDA
- 31 January 2017 NAI US FDA
- 18 March 2014 NAI US FDA
- 17 November 2011 NAI US FDA
- 21 December 2010 NAI US FDA
- 24 March 2010 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| GAINESVILLE, United States | Not on file |
| Gainesville, United States | 1035761 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| NPRA (MY) | 2 | None |
| FDA (GH) | 1 | None |
| ANVISA (Brazil) | None | 1 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 19 November 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates