# FDA 483 - RK Pharma Inc. - May 31, 2024

Source: https://www.keypedia.com/records/483/rk-pharma-inc/e37ee092-9fd9-4edf-93b7-2e81b4fb6f6b

> FDA 483 for RK Pharma Inc. on May 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RK Pharma Inc.
- Inspection Date: 2024-05-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: RK Pharma Inc. in Pearl River, NY, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in equipment qualification, cleaning validation, laboratory controls for visual inspection, data integrity for electronic audit trails, and record-keeping for rejected drug products. These issues indicate a lack of robust quality systems impacting the safety, identity, strength, quality, and purity of their drug products.

## Related Documents

- [483 - 2022-08-12](https://www.keypedia.com/records/483/rk-pharma-inc/5e26c4c2-1c01-4674-bfd8-3146fd524e34)
- [483 - 2025-08-28](https://www.keypedia.com/records/483/rk-pharma-inc/eb5c7d5d-c81f-45ea-be5e-0b359bb7dde1)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Ruben C. Quintana](https://www.keypedia.com/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)

Company: https://www.keypedia.com/companies/rk-pharma-inc/04d6c855-6dac-45ed-8597-0541bddd3bce

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961