# FDA 483 - Osmotica Pharmaceutical US LLC - January 18, 2019

Source: https://www.globalkeysolutions.net/records/483/osmotica-pharmaceutical-us-llc/dd6917d7-d982-478e-8df5-1e12a257cdbd

> FDA 483 for Osmotica Pharmaceutical US LLC on January 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Osmotica Pharmaceutical US LLC
- Inspection Date: 2019-01-18
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Osmotica Pharmaceutical Corp in Marietta, GA, was inspected by the FDA from January 15-18, 2019. The inspection revealed a significant issue with the firm's GMP training program, specifically the failure to conduct annual training for employees. This observation is a repeat finding from a previous FDA-483 issued in 2013, indicating a persistent problem.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/gideon-n-esuzor/78dae9f4-77e9-469b-982d-2d4a42cc641f)

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