Lannett Company LLC – FDA 483, Oct 21, 2022

Lannett Company Inc. in Seymour, IN, a pharmaceutical manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate laboratory records with unreviewed deleted data and modifiable system dates, a quality control unit failing to close deviations within established timeframes, and batch production records lacking specific identification for in-process materials. These issues indicate a lack of control over data integrity and manufacturing processes.