FDA WARNING_LETTER - FARMAKEIO OUTSOURCING LLC - October 30, 2019

The FDA issued a Warning Letter to FarmaKeio Outsourcing LLC following an October 2019 inspection, finding that the 503B-registered facility produced drugs failing to meet conditions for exemptions from drug approval, adequate directions for use, and DSCSA requirements. Violations included non-compliance with FDCA section 503B(b)(5) for adverse event (AE) reporting, citing inadequate SOPs that failed to define serious AEs, lacked follow-up report information, and omitted references to the Safety Reporting Portal/Electronic Submission Gateway, as required by 21 CFR 310.305 and 21 CFR 211.198. The firm was also cited for marketing unapproved new drugs, violating FDCA sections 505(a) and 301(d). Compounded products were misbranded under section 502(f)(1) due to inadequate directions for use, constituting prohibited acts under sections 301(a) and 301(k). Additionally, compounded Testosterone Pellets were deemed "essentially a copy" of approved drugs, violating 503B(a)(5), and product labeling lacked the required "This is a compounded drug" statement per 503B(a)(10). The firm's initial corrective actions were found inadequate. FarmaKeio must promptly correct all violations and respond to the FDA within fifteen working days with detailed steps and supporting documentation. Non-compliance risks legal action, including seizure and injunction, and continued ineligibility for 503B exemptions.