FDA 483 - LightStone Medical Llc - June 25, 2021

An FDA inspection of LightStone Medical Llc, an importer of medical devices located in Brooklyn, NY, revealed significant deficiencies in their quality system. The firm was cited for failing to establish adequate procedures for accepting incoming products, handling customer complaints, and developing written Medical Device Reporting (MDR) procedures. These observations indicate a lack of fundamental controls for ensuring product quality and regulatory compliance.