FDA 483 - Neurolign USA, Llc - October 13, 2022

An FDA inspection of Neurolign USA, llc in Pittsburgh, PA, revealed three observations related to their manufacturing practices. The firm was cited for not establishing quality control procedures for electronic product radiation safety, failing to submit required annual reports for their products, and not affixing permanent certification labels to their medical devices. These issues indicate deficiencies in regulatory compliance concerning product safety and reporting.