FDA 483 - homechoice partners - August 04, 2021

During an inspection conducted from August 2 to August 9, 2021, the Food and Drug Administration (FDA) issued a Form FDA 483 to HomeChoice Partners dba BioScrip Infusion Services, a producer of sterile drug products located in Augusta, GA. The report highlighted significant observations indicating potential risks to the sterility of their products.

Key issues included the use of non-sterile disinfecting agents and cleaning pads in the critical ISO 5 aseptic processing area, a repeat observation. Specifically, an unsealed package of wipes was found in an ISO 7 environment and subsequently used for sanitizing components entering the ISO 5 area. Additionally, the firm lacked adequate smoke studies performed under dynamic conditions that accurately mimicked aseptic processing. Inspectors observed multiple personnel working simultaneously in a single hood during sterile drug production, while the company's smoke study video only depicted one technician, failing to represent actual operational airflow and potential contamination risks.

These observations indicate practices that may compromise drug sterility, falling under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. The company is expected to implement prompt and effective corrective actions to address these conditions and ensure full compliance with current good manufacturing practices for sterile drug production.