FDA 483 - New Era Pharmacy, LLC - November 27, 2019

During an FDA inspection conducted from November 21-27, 2019, New Era Pharmacy, LLC, a producer of sterile and non-sterile drugs, received a Form FDA 483 detailing several significant observations related to its manufacturing practices. One key observation noted that protective apparel was not appropriately worn to prevent drug product contamination, specifically during sterile production where an employee's non-sterile gown sleeves were inside an ISO 5 Biological Safety Cabinet. Furthermore, the firm's ISO 5 classified areas lacked adequate dynamic certification, as smoke studies were deficient in verifying operator movement and interventions during critical aseptic processes. The inspection also identified that media fills, designed to simulate aseptic production and challenge sterility, did not accurately represent worst-case conditions, such as varying container sizes, maximum personnel, or full production durations. Finally, New Era Pharmacy was found to be using non-pharmaceutical grade components in non-sterile drug products without conducting necessary analytical or microbiological testing to confirm they met required specifications. These observations highlight critical deviations from established quality standards for drug manufacturing. The issuance of a Form FDA 483 requires New Era Pharmacy, LLC to provide a formal response outlining comprehensive corrective actions to address these deficiencies and ensure the quality and safety of its drug products.