# FDA 483 - Societal CDMO Gainesville, LLC - November 19, 2024

Source: https://www.globalkeysolutions.net/records/483/societal-cdmo-gainesville-llc/9abe7452-c96f-4ad6-91f7-7bff4195ffd0

> FDA 483 for Societal CDMO Gainesville, LLC on November 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Societal CDMO Gainesville, LLC
- Inspection Date: 2024-11-19
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Societal CDMO Gainesville, LLC in Gainesville, GA, revealed a significant deficiency in computer system controls. The firm's data integrity standard operating procedures were found inadequate, specifically lacking requirements for periodic audit trail reviews and clear frequencies for project audit trail reviews. This indicates a moderate severity issue related to data integrity and record management.

## Related Documents

- [483 - 2019-08-12](https://www.globalkeysolutions.net/records/483/societal-cdmo-gainesville-llc/44334b9e-433a-42ea-8b7b-ff4347c8ee71)

## Related Officers

- [Susan O. Oladeji](https://www.globalkeysolutions.net/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

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

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