FDA 483 - Carolina Infusion - August 18, 2026

Between August 5 and August 18, 2026, the FDA inspected Carolina Infusion, LLC, a sterile and non-sterile drug manufacturer in Ridgeland, South Carolina. The inspection revealed several critical safety and quality control deficiencies that call into question the safety and purity of the firm’s drug products, including Tirzepatide. Primary violations include a failure to maintain appropriate airflow and pressure in sterile processing areas, the use of inadequate preservatives for multi-dose drugs, and flawed sterility testing methods that do not accurately represent production conditions. The facility’s design was also found to be inadequate, with dust-collecting surfaces, exposed insulation, and the presence of dead cockroaches in areas adjacent to production. Of significant concern was the lack of segregation between hazardous substances; chemotherapy drugs, potent hormones, and biohazardous materials were processed in the same area without proven decontamination protocols. Additionally, the firm reprocessed and released drugs after equipment failures, creating a high risk of cross-contamination and sub-standard product quality. These observations were issued under the Federal Food, Drug, and Cosmetic (FD&C) Act. Carolina Infusion is required to respond to these findings by detailing their corrective actions or submitting objections to the FDA to ensure future compliance with safety standards.