FDA WARNING_LETTER - Pharmakon Compounding Pharmacy, Inc. - May 06, 2016

An FDA inspection of Pharmakon Compounding Pharmacy, Inc. from April 18 to May 6, 2016, revealed serious deficiencies in sterile drug product production, posing patient risks. The firm's drug products failed to meet Section 503A of the FDCA conditions, specifically by not receiving valid prescriptions for individually-identified patients, rendering them ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements. Consequently, these products are considered adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B) due to insanitary conditions and significant CGMP violations, including failures in aseptic process validation (21 CFR 211.113(b)), equipment maintenance (21 CFR 211.42(c)(10)(vi)), environmental monitoring (21 CFR 211.42(c)(10)(iv)), and final product testing for specifications (21 CFR 211.165(a)) and sterility/pyrogenicity (21 CFR 211.167(a)). Additionally, the compounded products are unapproved new drugs (FDCA 505(a), 301(d)) and misbranded (FDCA 502(f)(1), 301(a), 301(k)) as they lack adequate directions for use. While the firm submitted responses, FDA found them inadequate, particularly regarding disinfection procedures and addressing turbulent airflow in isolators. FDA recommends a comprehensive assessment, possibly with a third-party consultant, and requires a written response within 15 working days detailing corrective actions to prevent legal action, including seizure and injunction.