FDA 483 - Metropolis International LLC - January 27, 2023

Metropolis International LLC, a medical device refurbisher in Long Island City, NY, received a Form FDA 483 with four observations during an inspection. The firm was cited for significant deficiencies in its quality system, specifically regarding the lack of established procedures and adequate documentation for complaint handling, corrective and preventive actions (CAPA), and process controls for refurbished devices.