483
RK Pharma Inc.RK Pharma Inc. – FDA 483, May 31, 2024
Record Details
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.
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ID · e37ee092-9fd9-4edf-93b7-2e81b4fb6f6b
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