FDA WARNING_LETTER - Empower Clinic Services, LLC dba Empower Pharmacy - October 04, 2024

The FDA issued a Warning Letter to Empower Clinic Services, LLC dba Empower Pharmacy following an inspection from September 24 to October 4, 2024. The inspection revealed serious deficiencies in drug product production, leading to drug products being adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions. Key violations included failure to perform adequate routine environmental monitoring, media fills not conducted under challenging conditions, and failure to appropriately sterilize equipment in the ISO 5 area, specifically the stopper sorting bowl and associated components. These acts are prohibited under sections 301(a) and 301(k) of the FDCA. The FDA reviewed the firm's responses to the Form FDA 483 but found several proposed corrective actions inadequate due to insufficient information or supporting documentation, particularly concerning ISO-5 room certification, environmental monitoring alert levels, and the completion of media fills. The FDA strongly recommended a comprehensive assessment of operations, especially aseptic processing, with assistance from a third-party consultant. The firm must address these violations promptly, providing a written response detailing specific steps and preventative measures within fifteen working days, or face potential legal action, including seizure and injunction.