FDA 483 - Metropolis International LLC - February 28, 2020

An FDA inspection of Metropolis International LLC, a manufacturer in Long Island City, NY, revealed significant deficiencies in their quality system. Observations included a lack of documented equipment calibrations, undeveloped written Medical Device Reporting (MDR) procedures, and unestablished procedures for corrective and preventive actions. Notably, the issues regarding MDR and CAPA procedures were repeat observations from a previous inspection.