# FDA 483 - Societal CDMO Gainesville, LLC - August 12, 2019

Source: https://www.keypedia.com/records/483/societal-cdmo-gainesville-llc/44334b9e-433a-42ea-8b7b-ff4347c8ee71

> FDA 483 for Societal CDMO Gainesville, LLC on August 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Societal CDMO Gainesville, LLC
- Inspection Date: 2019-08-12
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Recro Gainesville LLC, a drug manufacturer in Gainesville, GA, revealed significant deficiencies in laboratory record-keeping and the quality control unit's investigation processes. Specifically, the firm failed to maintain complete analytical data and adequately investigate non-conformances and out-of-specification results. These issues indicate a lack of robust quality assurance and data integrity practices.

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## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

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