# Societal CDMO Gainesville, LLC – FDA Inspection, Feb 27, 2026

Source: https://www.keypedia.com/records/fda_inspections/societal-cdmo-gainesville-llc/45e3cdb2-8c04-4189-a68d-55f0a837bfbd
Source feed: FDA_Inspections

> FDA inspection 1304712 of Societal CDMO Gainesville, LLC, February 27, 2026. Classification: Official Action Indicated (OAI). 3 citations under 21 CFR part 211. Form 483 issued. 8 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1304712
- Company Name: Societal CDMO Gainesville, LLC
- Inspection Date: 2026-02-27
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: New Drug Evaluation
- Product Type: Human Drugs
- Center: Human Drugs
- Office Name: Atlanta District Office
- Citation Count: 3

## Related Documents

- [FDA Inspection 1254528 - 2024-11-19](https://www.keypedia.com/records/fda_inspections/societal-cdmo-gainesville-llc/f4f01c73-3322-40fd-b040-8cccd91e2fa6)
- [FDA Inspection 1099417 - 2019-08-12](https://www.keypedia.com/records/fda_inspections/societal-cdmo-gainesville-llc/e825f950-39b8-4e89-97ec-02e331e98ab6)
- [FDA Inspection 1038575 - 2018-01-24](https://www.keypedia.com/records/fda_inspections/societal-cdmo-gainesville-llc/ec304c27-5b63-4841-bd1c-aab795d7540a)
- [FDA Inspection 1019509 - 2017-01-31](https://www.keypedia.com/records/fda_inspections/societal-cdmo-gainesville-llc/8dc29ed6-64b9-4e2a-811b-05bfe1969a88)
- FDA Inspection 870449 - 2014-03-18

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/amit-kokate/3c764e30-3a6f-4496-840a-30b678c0b3b8)
- [FDA Associated Person](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.keypedia.com/companies/societal-cdmo-gainesville-llc/6a502520-0ac5-48a2-ac38-7b93e63598cb

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7