FDA 483 - Unknown Company - July 14, 2023

During an inspection conducted from July 6 to July 14, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Sentara Enterprises, operating as Sentara Infusion Services (Blue Ridge), a producer of sterile drug products in Charlottesville, VA. The inspection revealed several significant observations concerning the firm's aseptic processing and environmental controls, indicating potential risks to product sterility and patient safety. Key issues observed included technicians blocking "first air" within ISO 5 classified areas during sterile manipulations and performing aseptic tasks with exposed skin and hair. Furthermore, the facility failed to adequately disinfect supplies when moving them from areas of lower to higher air quality. Critical deficiencies were also noted in process validation: media fills did not accurately simulate aseptic production, lacking representative container-closure types, equipment, and product volumes. Additionally, smoke studies, intended to verify unidirectional airflow, were inadequately performed under dynamic conditions, failing to represent actual production processes and equipment usage. These observations suggest conditions where drug products may have been prepared or held under insanitary conditions, potentially leading to contamination, as outlined under Section 704(b) of the Federal Food, Drug and Cosmetic Act. Sentara Infusion Services is required to respond to these findings, detailing corrective actions implemented or planned, to ensure compliance with regulatory standards for sterile drug manufacturing.