FDA 483 - sentara enterprises - July 14, 2023

On July 14, 2023, the FDA issued a Form 483 to Sentara Enterprises dba Sentara Infusion Services (Blue Ridge), a producer of sterile drug products located at 920 E High St, Charlottesville, VA. The inspection, conducted from July 6-14, 2023, identified five observations related to aseptic processing and quality control.

Observation 1 noted personnel blocking "first air" in the ISO 5 area during aseptic manipulations, specifically a technician blocking airflow with their hand while making connections for MYCAMINE 100MG. Observation 2 cited personnel performing aseptic manipulations with exposed hair or skin, with a technician observed leaning into the ISO 5 hood with exposed skin around the eyes and forehead while preparing SOLUMEDROL 1GM. Observation 3 detailed a lack of disinfection of supplies, as a technician introduced a sterile IPA bottle into the ISO 5 hood without sanitizing its outer surface.

Observation 4 highlighted the failure to conduct media fills that adequately simulate aseptic production, specifically noting that media fills did not include representative container-closure types (elastomeric pumps, large IV bags), equipment (automated compounding device), or the quantity and volume of finished drug products per order. Finally, Observation 5 stated that smoke studies were inadequately performed under dynamic conditions, as they did not verify unidirectional airflow under conditions representative of typical production processes, such as the use of an automated compounding device