483
Novus Surgical Solutions LLCNovus Surgical Solutions LLC – FDA 483, Apr 1, 2022
Record Details
An FDA inspection of Novus Surgical Solutions LLC, a human tissue distributor in Allentown, PA, revealed significant deficiencies in its quality program. The firm failed to establish core Current Good Tissue Practice (CGTP) requirements, including quality audits, controlled storage areas, and procedures for product receipt and returns. Additionally, the firm lacked established procedures for equipment calibration.
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ID · 9cabea7a-9a96-4f19-8444-6abee8b3b8cf
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