RK Pharma Inc.,November 14, 2025

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

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Record Details

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.

Company: RK Pharma Inc.,
Inspection Date: November 14, 2025
Product Type: Drugs
Office: New Jersey District Office
Person: Yvins Dezan

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ID · 9fa1b108-d88e-4f28-aa90-bf3d60e4be82