FDA Inspection
Societal CDMO Gainesville, LLCSocietal CDMO Gainesville, LLC – FDA Inspection, Aug 12, 2019
Record Details
This FDA Inspection record concerns Societal CDMO Gainesville, LLC, with an inspection on August 12, 2019, issued by the Atlanta District Office, covering human drugs.
View Company Profile
ID · e825f950-39b8-4e89-97ec-02e331e98ab6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099417
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Societal CDMO Gainesville, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2026 | OAI | Atlanta District Office | New Drug Evaluation |
| November 19, 2024 | VAI | Atlanta District Office | Drug Quality Assurance |
| January 24, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 31, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Societal CDMO Gainesville, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.