# FDA 483 - Rpk Pharmaceuticals Inc - October 14, 2021

Source: https://www.keypedia.com/records/483/rpk-pharmaceuticals-inc/ee539f9e-8088-44ee-9bc1-4548c62fb828

> FDA 483 for Rpk Pharmaceuticals Inc on October 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rpk Pharmaceuticals Inc
- Inspection Date: 2021-10-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of RPK Pharmaceuticals Inc, a drug repackaging/relabeling facility in Union City, CA, revealed significant deficiencies. The firm failed to follow written procedures for handling expired products and maintaining reserved samples. Additionally, cleaning and maintenance procedures for equipment were found to be deficient, with expired cleaning supplies observed in use.

## Related Documents

- [483 - 2019-02-25](https://www.keypedia.com/records/483/rpk-pharmaceuticals-inc/b07f1920-c28f-4f7f-b39f-845b70b9bbcc)

## Related Officers

- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)
- [Stryker, Regulatory Affairs](https://www.keypedia.com/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

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

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