FDA 483 - Infusion Partners, LLC - January 26, 2018

This FDA Form 483 was issued to Infusion Partners, LLC in Canfield, OH, following an inspection from January 22-26, 2018. The inspection revealed significant deficiencies in aseptic processing areas, including visibly dirty equipment, inadequate disinfection practices, improper personnel behavior, and facility design flaws. These observations indicate a high risk of contamination for sterile drug products.