FDA inspection
Societal CDMO Gainesville, LLC: FDA inspection ending Feb 27, 2026
FDA inspection 1304712 · Official Action Indicated (OAI) · Gainesville, GA
Key facts
| Inspection ID | 1304712 |
|---|---|
| Firm | Societal CDMO Gainesville, LLC |
| FEI number | 1035761 |
| Address | 1300 Gould Dr |
| City | Gainesville |
| State | GA |
| ZIP | 30504-3947 |
| Fiscal year | 2026 |
| Inspection end date | Feb 27, 2026 |
| Classification | Official Action Indicated (OAI) |
| Project area | New Drug Evaluation |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data