Nucrogene IncOctober 9, 2024

FDA 483 - Nucrogene Inc - October 09, 2024

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Record Details

Nucrogene Inc, a drug manufacturer in Branchburg, NJ, was cited for significant deficiencies during an FDA inspection. The firm failed to follow its stability testing program, lacked appropriate controls for computer systems including audit trail reviews, and did not complete equipment cleaning validation for tablet presses. Additionally, annual product reviews were not conducted as required.

Company: Nucrogene Inc
Inspection Date: October 9, 2024
Product Type: Drugs
Office: New Jersey District Office
People: Alisha B. Patel
Victoria Spivak (Pharmacist | Consumer Safety Officer)

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ID · 482e5d3d-0a53-4ba9-9cb2-50047cfc6a2a