FDA 483 - Fallon Wellness Pharmacy, L.L.C. - December 06, 2016

During an inspection conducted from November 1 to December 6, 2016, Fallon Wellness Pharmacy, LLC, a producer of sterile drug products, received an FDA Form 483 outlining significant observations related to its manufacturing practices. The primary concerns included a failure to thoroughly investigate out-of-specification environmental monitoring results, with instances of Penicillium spp. and Bacillus contamination in cleanrooms during sterile processing. The company also demonstrated deficiencies in maintaining aseptic conditions, such as uncalibrated particle counters and sterilizers, and the use of non-sterile materials in cleanroom environments. Furthermore, Fallon Wellness Pharmacy lacked essential procedures to prevent microbiological contamination, including the absence of stability and sterility studies for high-risk sterile drug products and stock solutions, and unvalidated sterilization cycles. The firm failed to adequately test every sterile drug for sterility and endotoxins, and its contract laboratory's testing methods were not compliant with USP standards. Other issues highlighted included inadequate exhaust systems, insufficient environmental monitoring for air pressure differentials, and a lack of segregated areas for processing different drug types, posing a cross-contamination risk. Many of these observations were repeats from a previous inspection. The company is required to implement comprehensive corrective actions to address these deficiencies and ensure compliance with regulatory standards for sterile drug production.