FDA 483 - homechoice partners, inc. - September 19, 2018

From September 10-19, 2018, the FDA inspected HomeChoice Partners, Inc. dba Bioscrip Infusion Services, a producer of sterile drug products located at 528 Trade Center Blvd, Chesterfield, MO. The inspection, led by Investigator Tiara N Brown-Crosen, resulted in two observations detailed in Form 483 issued to General Manager Joshua R. Clinard.

Observation 1 noted the production of beta-lactam drugs (e.g., Ceftriaxone, Cefazolin) in the same ISO 5 area as non-beta-lactam drugs without adequate cleaning of work surfaces to prevent cross-contamination. The firm's cleaning procedure lacked identification of appropriate cleaning agents for this purpose.

Observation 2 detailed instances where personnel touched surfaces outside the ISO 5 aseptic processing area with gloved hands and then continued aseptic processing without changing or sanitizing gloves. Specifically, on September 10, 2018, during the production of Tigecycline, Vancomycin, Ceftriaxone, and Cefazolin, a technician touched a supply cart and operated a fluid dispensing pump in the ISO 7 IV Room, then continued aseptic processing in the ISO 5 LFH without glove change or sanitization.