Novus Surgical Solutions LLCApril 1, 2022

FDA 483 - Novus Surgical Solutions LLC - April 01, 2022

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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.

Company: Novus Surgical Solutions LLC
Inspection Date: April 1, 2022
Product Type: Biologics
Office: Philadelphia District Office
Person: Cara Minelli (issuing_officer)

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ID · 9cabea7a-9a96-4f19-8444-6abee8b3b8cf