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

An FDA Pre-Approval and routine surveillance inspection of Legacy Pharmaceutical Packaging LLC, a non-sterile drug repackaging firm located in Earth City, MO, took place from January 16-25, 2019. This abbreviated cGMP inspection focused on the company's quality, packaging, and labeling systems, conducted under FDA compliance programs for pre-approval inspections and drug repackaging/manufacturing. The primary violation identified, documented in a one-item Form FDA 483, concerned the firm's failure to provide adequate training to its employees. Specifically, two out of three reviewed employees did not receive required GMP training in 2017, no GMP training was conducted in 2018, and an untrained employee performed critical equipment setup in 2018 without proper trainer oversight, which led to inconsistent tablet counts. These deficiencies directly violated regulatory framework 21 CFR 211.25(a) and the company's own standard operating procedures. As a required action, Legacy Pharmaceutical Packaging LLC management verbally acknowledged the observations and committed to providing a written response addressing these issues within 15 business days, emphasizing their responsibility to comply with the FD&C Act.