FDA 483 - Carolina Infusion - August 12, 2022

Carolina Infusion, a producer of sterile and non-sterile drug products in Ridgeland, SC, was cited for significant deficiencies in its manufacturing processes. Observations included inadequate endotoxin control for intrathecal products, insufficient media fill challenges, uncertified ISO-5 areas under dynamic conditions, and critical issues with facility environmental control, including pathogenic microbial contamination and the use of non-pharmaceutical grade components. These findings indicate a serious lack of assurance in the sterility and quality of drug products.