FDA 483 - Fallon Wellness Pharmacy, L.L.C. - March 10, 2015

Fallon Wellness Pharmacy, L.L.C. received an FDA Form 483 following an inspection conducted from March 2-10, 2015. The facility, a producer of sterile drug products, was cited for numerous significant deviations from regulatory expectations concerning the manufacturing of sterile drug products. Key observations included critical deficiencies in maintaining aseptic processing environments, such as lacking dynamic smoke studies, an anteroom door that could not close properly, and a cluttered cleanroom. Personnel practices were also a major concern, with operators observed wearing non-sterile attire, reusing gowns, and having exposed skin during sterile operations. Furthermore, the pharmacy failed to thoroughly investigate sterility failures for recalled products and environmental contamination, indicating a lack of robust quality control. Environmental monitoring was inadequate, lacking daily viable air sampling and regular microbial surface testing in critical zones. Cleaning and disinfection procedures were also deficient, utilizing non-sterile disinfectants without sporicidal agents or effectiveness studies. The inspection also revealed a lack of validated procedures to prevent microbiological contamination, including the absence of media fills, stability and sterility studies for intermediate products, and validated sterilization processes. The firm did not test every sterile drug lot for sterility or endotoxins, and its testing methods were unvalidated. Additionally, there were no dedicated areas to prevent cross-contamination between different drug types, such as beta-Lactam and non-beta-Lactam injectables. Finally, the company lacked a stability testing program to support assigned Beyond Use Dates and failed to review certificates of analysis for sterile containers and equipment. These observations collectively indicate systemic failures to ensure the sterility, quality, and safety of drug products. Fallon Wellness Pharmacy is required to implement comprehensive corrective actions to address these deficiencies and achieve compliance with current Good Manufacturing Practices.