Novus Surgical Solutions LLCMay 8, 2025

FDA 483 - Novus Surgical Solutions LLC - May 08, 2025

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Record Details

An FDA inspection of Novus Surgical Solutions LLC in Allentown, PA, on May 8, 2025, revealed a significant procedural lapse. The firm failed to implement and follow written procedures and schedules for the calibration of measuring equipment. This indicates a potential risk to quality control and product integrity.

Company: Novus Surgical Solutions LLC
Inspection Date: May 8, 2025
Product Type: Biologics
Office: Philadelphia District Office
Person: Michele Gottshall

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ID · ab729aff-8dd1-4f18-959b-e79bf2f28cc5