# FDA 483 - Societal CDMO Gainesville, LLC - February 27, 2026

Source: https://www.keypedia.com/records/483/societal-cdmo-gainesville-llc/bfc4a87d-e370-4d7e-ab85-5c0ea99ba5b5

> FDA 483 for Societal CDMO Gainesville, LLC on February 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Societal CDMO Gainesville, LLC
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Societal CDMO Gainesville, LLC, a manufacturer of prescription solid oral drugs, was cited for significant deficiencies during an FDA inspection. Observations included inadequate production and process controls for drug product quality, failure to thoroughly review unexplained discrepancies in blend uniformity, and insufficient controls over computer systems for master production records. These issues collectively indicate a lack of robust quality assurance and control over critical manufacturing processes.

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- [483 - 2024-11-19](https://www.keypedia.com/records/483/societal-cdmo-gainesville-llc/9abe7452-c96f-4ad6-91f7-7bff4195ffd0)
- [483 - 2026-02-27](https://www.keypedia.com/records/483/societal-cdmo-gainesville-llc/8aca8323-ae3b-48fd-a6e1-82cf4597f762)

## Related Officers

- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Amit Kokate](https://www.keypedia.com/people/amit-kokate/3c764e30-3a6f-4496-840a-30b678c0b3b8)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6