FDA Inspection
Societal CDMO Gainesville, LLCSocietal CDMO Gainesville, LLC – FDA Inspection, Feb 27, 2026
Record Details
This FDA Inspection record concerns Societal CDMO Gainesville, LLC, with an inspection on February 27, 2026, issued by the Atlanta District Office, covering human drugs.
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ID · 45e3cdb2-8c04-4189-a68d-55f0a837bfbd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1304712
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Societal CDMO Gainesville, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2024 | VAI | Atlanta District Office | Drug Quality Assurance |
| August 12, 2019 | VAI | Atlanta District Office | New Drug Evaluation |
| 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 |
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