FDA 483 - Legacy Pharmaceutical Packaging LLC - January 25, 2019

Legacy Pharmaceutical Packaging LLC, a contract packager and repackager in Earth City, MO, was cited for significant deficiencies in its employee training program. The firm failed to provide required GMP training in 2017 and 2018, and an untrained employee was involved in an operational error leading to inconsistent tablet counts. These issues indicate a systemic failure to adhere to personnel training requirements and current good manufacturing practices.