483
Nucrogene IncNucrogene Inc – FDA 483, Oct 9, 2024
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.
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ID · 482e5d3d-0a53-4ba9-9cb2-50047cfc6a2a
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