# FDA 483 - Rpk Pharmaceuticals Inc - February 25, 2019

Source: https://www.globalkeysolutions.net/records/483/rpk-pharmaceuticals-inc/b07f1920-c28f-4f7f-b39f-845b70b9bbcc

> FDA 483 for Rpk Pharmaceuticals Inc on February 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rpk Pharmaceuticals Inc
- Inspection Date: 2019-02-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: RPK Pharmaceuticals Inc. dba Pharmedix in Union City, CA, a repacker/relabeler, was inspected from February 25-28, 2019. The inspection revealed significant deficiencies related to employee training and adherence to sanitation procedures, specifically the use of expired hand sanitizer. These issues indicate a lack of control over personnel qualifications and environmental conditions that could impact drug product quality.

## Related Documents

- [483 - 2021-10-14](https://www.globalkeysolutions.net/records/483/rpk-pharmaceuticals-inc/ee539f9e-8088-44ee-9bc1-4548c62fb828)

## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.globalkeysolutions.net/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)

Company: https://www.globalkeysolutions.net/companies/rpk-pharmaceuticals-inc/4fcc57aa-1dbd-44d8-859b-3754c50751af

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b