FDA 483 - ImaCor Inc. - June 10, 2021

ImaCor Inc., a medical device manufacturer in Jericho, NY, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection found that the firm failed to maintain written Medical Device Reporting (MDR) procedures, inadequately maintained complaint files, and lacked proper documentation of approval for critical documents. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.