FDA 483 - new vitals pharmacy llc - July 05, 2023

This FDA Form 483 document outlines several significant observations made during an inspection of a sterile drug product manufacturing facility. The facility demonstrated a failure to conduct post-use filter-integrity testing on filters used to sterilize drug products, a critical step for ensuring sterility. Media fills, which are crucial for simulating aseptic production, were not conducted under conditions that closely represent worst-case, most-challenging, and stressful scenarios.

Several issues related to aseptic technique and environmental control were noted. These include blocking first air by placing supplies in the ISO 5 Laminar Flow Hood (LFH), and a lack of sporicidal agent use in the facility's ISO 5 and other classified areas. The use of non-sterile cleaning wipes in the ISO 5 area further compromises sterility. Smoke studies, essential for airflow visualization, were inadequately performed under dynamic conditions.

Deficiencies in disinfection practices were observed, specifically insufficient disinfectant contact time to achieve adequate levels of disinfection. Personnel infrequently sanitized gloves, increasing contamination risk. Facility design issues were also cited, including unsealed HEPA filters around the perimeter and the influx of lesser quality air into a classified area containing higher quality air. Finally, the facility was found to be using processing aides not intended for pharmaceutical use in sterile drug production. These observations indicate significant deficiencies in quality control, aseptic processing, and facility design, potentially impacting the sterility and quality of drug products.