southern tier home infusion, inc. – FDA Warning Letter, Nov 30, 2022

An FDA inspection of Southern Tier Home Infusion, Inc. dba Pharmacy Innovations (Nov 2-30, 2022) revealed serious deficiencies in sterile drug production. The firm failed to meet section 503A conditions of the FDCA by not obtaining valid prescriptions for individually-identified patients for compounded products, rendering them ineligible for CGMP, labeling, and approval exemptions. Drug products were deemed adulterated under section 501(a)(2)(A) due to insanitary conditions. Violations included dirty ISO 5/7 areas, inadequate response to microbial contamination, poor airflow, insufficient HEPA filter coverage, inadequate smoke studies, and numerous poor aseptic practices by operators. Media fills were not challenging, sporicidal agents were not used, and sterilized materials were exposed to lower quality air. Consequently, these products are unapproved new drugs (sections 505(a), 301(d)) and misbranded (section 502(f)(1)) due to lacking adequate directions for use. While the firm initiated a recall and ceased sterile compounding in the non-hazardous ISO 5 LAFW, several proposed corrective actions were insufficient or lacked documentation, particularly regarding new equipment, aseptic retraining (a repeat observation), smoke studies, and media fill procedures. FDA recommends a comprehensive third-party assessment. The firm must respond within 15 working days with corrective actions or confirm cessation of sterile production, and notify FDA before resuming. Failure to comply may lead to legal action.