FDA 483 - Maimonides Medical Center - Pharmacy - March 09, 2023

Maimonides Medical Center - Pharmacy in Brooklyn, NY, was cited for significant deficiencies in its sterile drug production areas. The inspection revealed inadequate facility design and environmental controls in both the Emergency Department and Medical Intensive Care Unit satellite pharmacies. These issues, including poor air quality, contamination risks around ISO 5 laminar flow hoods, and improper cleanroom practices, indicate a high potential for contamination of sterile drug products.