FDA 483 - Mytilini Enterprises LLC dba Bedford Pharmacy Inc. - August 28, 2015

An FDA inspection of Bedford Pharmacy Inc. conducted from August 10 to August 28, 2015, revealed multiple significant deficiencies in their sterile drug product manufacturing. Issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, the inspection report detailed a lack of adequate controls and procedures essential for ensuring product quality and safety.Main violations included a severely deficient system for monitoring environmental conditions and personnel in aseptic processing areas, with no written procedures, dynamic smoke studies, routine pressure differential monitoring, or consistent sampling. Equipment maintenance also suffered, as the depyrogenation process for reusable glassware was not validated for endotoxin reduction, and media fills failed to incorporate such equipment. Cleaning and disinfection protocols were inadequate, exposing critical aseptic areas to unclassified air, lacking sporicidal agents, and using non-sterile wipes without proper assessment.Crucially, the firm failed to conduct essential sterility, endotoxin, and routine potency testing for various sterile drug products prior to release, and lacked written procedures for these tests. Additionally, expiration dates for several sterile injections (Bimix, Trimix, HPC) were not supported by adequate stability data. Bedford Pharmacy Inc. is required to implement comprehensive corrective actions to address these fundamental deficiencies and ensure compliance with current good manufacturing practices.