# FDA 483 - Osmotica Pharmaceutical US LLC - May 02, 2025

Source: https://www.keypedia.com/records/483/osmotica-pharmaceutical-us-llc/858c4816-6c76-4c2f-af14-b0b33a51786f

> FDA 483 for Osmotica Pharmaceutical US LLC on May 02, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Osmotica Pharmaceutical US LLC
- Inspection Date: 2025-05-02
- Product Type: other
- Office Name: Office of Health Technology 7 (In Vitro Diagnostics)
- Summary: Document content for the FDA 483 was not provided. Therefore, a summary including the company name, inspection dates, main violations/issues, regulatory framework, and required actions cannot be generated.

## Related Documents

- [483 - 2019-01-18](https://www.keypedia.com/records/483/osmotica-pharmaceutical-us-llc/dd6917d7-d982-478e-8df5-1e12a257cdbd)
- [483 - 2025-05-02](https://www.keypedia.com/records/483/osmotica-pharmaceutical-us-llc/3bf76edd-abb5-4dd7-afd7-8ebd23b81928)

## Related Officers

- [Samantha E. Cleek](https://www.keypedia.com/people/samantha-e-cleek/7305f28f-9c92-427d-86ec-42c0bb6bf3ce)

Company: https://www.keypedia.com/companies/osmotica-pharmaceutical-us-llc/5dae0d09-f070-4928-97f6-cfe7043ff133

Office: https://www.keypedia.com/offices/office-of-health-technology-7-in-vitro-diagnostics/19bfc7ca-52e3-49b8-84a6-14d7fd927811