FDA 483 - HomeChoice Partners dba BioScript Infusion Services - August 17, 2018

This FDA Form 483 was issued to HomeChoice Partners, Inc., a producer of sterile drug products, located at 2848 Washington Rd, Augusta, GA 30909-2356. The inspection was conducted from August 13-17, 2018, and the report was issued to David H. Jones, Pharmacy Manager.

Two observations were noted:

1. **Deficient Aseptic Processing Area Cleaning and Disinfection:** The system for cleaning and disinfecting equipment to produce aseptic conditions was found deficient, posing a risk to the sterility of the ISO 5 Laminar Flow Hood. Specific issues included: * Use of non-sterile gowns during sterile drug product production in the ISO 5 Laminar Flow Hood. * Failure to sanitize tubing connected to stock solutions in the ISO 5 Laminar Flow Hood between the production of different sterile drug products. An example on August 14, 2018, showed a Sterile Compounding Technician touching tubing multiple times without sanitizing it before producing a different drug. * Sterile wipes introduced for daily cleaning were left open and exposed in the ISO-5 area before, during, and after cleaning.

2. **Pest Infestation in Manufacturing Buildings:** Buildings used for drug product manufacture, processing, packing, or holding were not free of infestation. During cleanroom cleaning, two live insects were observed