# FDA 483 - RK Pharma Inc., - November 14, 2025

Source: https://www.globalkeysolutions.net/records/483/rk-pharma-inc/9fa1b108-d88e-4f28-aa90-bf3d60e4be82

> FDA 483 for RK Pharma Inc., on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: RK Pharma Inc.,
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: RK Pharma Inc., an analytical testing laboratory in East Windsor, NJ, received a Form 483 with four observations. The inspection revealed significant deficiencies in equipment qualification, data integrity controls, quality unit procedures, and employee training. These issues indicate a lack of adherence to current good manufacturing practices, potentially impacting the quality and reliability of their analytical testing.

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/rk-pharma-inc/751ce24a-cfc5-4e09-bd1f-ec3a6b8d1f19

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248