FDA WARNING_LETTER - advanced nutriceuticals, llc - October 29, 2020

An FDA inspection of Advanced Nutriceuticals LLC (The Guyer Institute) from October 13-29, 2020, revealed serious deficiencies in sterile drug production and failures to meet section 503A exemptions. The firm voluntarily ceased sterile production and recalled products due to sterility assurance concerns. Violations included compounding without valid patient-specific prescriptions and using bulk substances (e.g., (b)(4)) not eligible for 503A exemptions, making these products subject to new drug approval, adequate labeling, and CGMP requirements. Drug products were adulterated under section 501(a)(2)(A) due to insanitary conditions: aseptic operations outside ISO 5, an uncertified IV hood, no media fills, poor aseptic technique, compromised sterile stock solutions, non-sterile storage, no environmental monitoring, dirty equipment, and inadequate hazardous drug handling. Significant CGMP violations (section 501(a)(2)(B)) included failure to establish sterile product procedures (21 CFR 211.113(b)), ensure appropriate personnel clothing (21 CFR 211.28(a)), adequately process container closures (21 CFR 211.94(c)), monitor environmental conditions (21 CFR 211.42(c)(10)(iv)), maintain suitable facilities (21 CFR 211.42(a)), establish production/process control procedures (21 CFR 211.100(a)), prepare batch records (21 CFR 211.188(b)), and retest components (21 CFR 211.87). The compounded ineligible drugs are also unapproved new drugs (sections 505(a), 301(d)) and misbranded (section 502(f)(1)). Compounding with piracetam and producing biological products without an approved BLA were also noted. The FDA found the firm's corrective action response inadequate. A third-party consultant assessment is recommended if sterile drug production resumes. The firm must notify the FDA within 15 working days of corrective steps or intent not to resume, and 15 working days prior to resuming sterile production. Failure to correct violations may lead to legal action.