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

During an inspection from August 13-17, 2018, of HomeChoice Partners, Inc., a producer of sterile drug products located at 2848 Washington Rd, Augusta, GA, the FDA observed two deficiencies.

Observation 1 noted deficiencies in the system for cleaning and disinfecting equipment in aseptic processing areas, posing a risk to the sterility of the ISO 5 Laminar Flow Hood. Specific issues included the use of non-sterile gowns during sterile drug production, unsanitized tubing connected to stock solutions in the ISO 5 Laminar Flow Hood between different drug products, and sterile wipes left open and exposed in the ISO-5 area before, during, and after cleaning.

Observation 2 identified that buildings used for manufacturing were not free of vermin. Two live insects, including a spider, were observed in the ante room beyond the line of demarcation while a Sterile Compounding Technician was cleaning. The technician stepped on one insect and continued mopping.