FDA WARNING_LETTER - Carolina Infusion - August 12, 2022

The FDA issued a Warning Letter to Carolina Infusion following a July-August 2022 inspection, citing serious deficiencies in their production of non-sterile and sterile drug products. The firm failed to meet section 503A conditions by not receiving valid patient-specific prescriptions for some compounded products, thus losing exemptions from CGMP, labeling, and FDA approval requirements. Drug products intended to be sterile were adulterated under section 501(a)(2)(A) due to insanitary conditions. Violations included using unverified materials for endotoxin control, poor facility design allowing air influx, using non-pharmaceutical grade components, inadequate media fills, and ISO-5 areas not dynamically certified. The firm also produced unapproved new drugs (sections 505(a), 301(d)) and misbranded drugs (section 502(f)(1)) lacking adequate directions for use. While the firm recalled sterile products and ceased intrathecal production, many corrective actions were deemed inadequate or lacked documentation. These included issues with endotoxin testing, component verification, certification reports, and environmental monitoring. Unaddressed concerns involved endotoxin control and limits for intrathecal products, inadequate pressure differentials, and media fills not reflecting complex compounding. The FDA strongly recommended a comprehensive third-party assessment, especially if sterile intrathecal production resumes. Failure to address violations could lead to legal action.