FDA 483 - carepoint healthcare, llc - August 24, 2017

This FDA Form 483 details observations from an inspection on July 19-20, 2017, concerning the aseptic processing of sterile drug products, specifically Ampicillin-Sulbactam and Ceftriaxone for Injection USP.

Key violations include: 1. **Poor Aseptic Technique by Personnel**: A technician touched sterile gown apparel and gloves with bare hands before sanitizing or incorrectly, potentially contaminating them. The technician was observed leaning into the Laminar Air Flow Hood (LAFH) with exposed skin around the eyes and did not allow sufficient drying time for sterile alcohol on gloves after cleaning before proceeding with sterile production. 2. **Inadequate Disinfection of Materials and Equipment**: Equipment, materials, and supplies were not disinfected prior to entering aseptic processing areas. The technician did not spray all sterile supplies with sterile alcohol before placing them in the ISO 5 area of the LAFH. Non-sterile materials, such as the outside of a sterile alcohol bottle, were brought into the ISO 5 area without prior wiping. Unnecessary equipment (TPN machine, balance) was present in the ISO 5 area without being wiped with sterile alcohol. An open bag of sterile wipes was observed in the ISO 7 area, compromising their sterility. 3. **Deficient Cleaning and Disinfection of Aseptic Areas**: Aseptic processing areas and equipment were not cleaned and disinfected according to SOP Pharmacy Compounding of Non