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

Source: https://www.keypedia.com/records/483/osmotica-pharmaceutical-us-llc/3bf76edd-abb5-4dd7-afd7-8ebd23b81928

> FDA 483 for Osmotica Pharmaceutical US LLC on May 02, 2025. Product: drugs. 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: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Osmotica Pharmaceutical US LLC revealed significant deficiencies in their manufacturing operations. Findings included inadequate process validation for Methylphenidate HCL ER Tablets, deficient investigations into deviations and complaints, and a failure to follow established written procedures for production, quality control, and complaint handling. The observations highlight a need for improved quality system oversight and employee training to ensure drug product quality and compliance.

## Related Documents

- [483 - 2019-01-18](https://www.keypedia.com/records/483/osmotica-pharmaceutical-us-llc/dd6917d7-d982-478e-8df5-1e12a257cdbd)

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [Tomika L. Crafter](https://www.keypedia.com/people/tomika-l-crafter/6c8260a0-c026-496d-80f6-9c30877e8f52)
- [Andrew O. Ejiofor](https://www.keypedia.com/people/andrew-o-ejiofor/6f256c75-79a4-41a0-a51b-480d5db8f3da)
- [Samantha E. Cleek](https://www.keypedia.com/people/samantha-e-cleek/7305f28f-9c92-427d-86ec-42c0bb6bf3ce)
- [Veronica Kientah](https://www.keypedia.com/people/veronica-kientah/8e466fde-81dd-4c20-b3c0-c761ebf51460)

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

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