FDA 483 - DuoProSS Meditech Corporation - August 12, 2022

DuoProSS Meditech Corporation, a medical device distributor in Farmingdale, NY, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to maintain written procedures for Medical Device Reporting (MDR), lacking timely communication to FDA. Additionally, the inspection revealed an absence of established procedures for corrective and preventive actions (CAPA) and acceptance activities related to the distribution of safety syringes and hypodermic needles.