FDA 483 - Essential Pharmacy Compounding - July 27, 2017

An FDA inspection of Essential Pharmacy Compounding LLC in Omaha, NE, conducted from July 10 to July 27, 2017, resulted in a Form FDA 483 detailing significant observations concerning the firm's sterile drug production practices. The inspection revealed potential deviations from current Good Manufacturing Practices intended to ensure product quality and safety.

Three primary issues were identified. Firstly, the company failed to adequately clean equipment and materials following smoke studies in the ISO 5 laminar flow hood, with no documented verification that residues from the smoke were removed. Secondly, personnel engaged in aseptic processing did not prevent cross-contamination; a technician was observed using a single wipe to clean both gloved hands and the ISO 5 hood surface when switching between different compounded products. Lastly, non-sterile disinfecting agents were improperly used in the critical ISO 5 aseptic processing area, as disinfectants were diluted with non-sterile water, introducing a contamination risk. Essential Pharmacy Compounding LLC is required to address these observations by implementing corrective actions to ensure compliance with regulatory standards, thereby safeguarding product integrity and patient safety.