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

During an inspection conducted from February 14 to March 9, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Maimonides Medical Center - Pharmacy in Brooklyn, NY. The inspection identified two significant observations related to the production of sterile and non-sterile drug products, indicating conditions that may lead to product contamination and non-compliance with quality standards, as outlined by the Federal Food, Drug and Cosmetic Act.

The first observation detailed deficiencies in the Emergency Department (ED) Satellite Pharmacy's segregated compounding area. Issues included inadequate environmental controls, such as an air-conditioner cassette positioned directly above the ISO 5 laminar flow hood and drug component staging area, with visible dust and debris. Furthermore, disposable non-sterile frocks were being reused and improperly stored, and a cleaning mop was stored inappropriately near the critical sterile compounding area. These conditions raise concerns about maintaining an acceptable sterile environment.

The second observation concerned the Medical Intensive Care Unit (MICU) Satellite Pharmacy, where a sink with a water supply was located approximately 1.2 meters from the ISO 5 laminar flow hood. An inspector observed a pharmacist using this sink for hand washing as part of the personnel gowning process before performing aseptic operations, which could compromise the sterile environment.

These observations highlight the need for Maimonides Medical Center - Pharmacy to implement robust corrective actions to ensure the integrity of its sterile compounding operations and prevent drug product contamination.