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

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.