FDA 483 - Legacy Pharmaceutical Packaging LLC - January 16, 2020

Legacy Pharmaceutical Packaging LLC, a medical device contract manufacturer in Earth City, MO, was cited for multiple deficiencies related to its quality system. The inspection revealed significant issues with process validation, particularly concerning its vision system for packaging, as well as inadequate documentation of rework, nonconforming product control, equipment maintenance, and complaint handling procedures. These observations indicate a lack of robust quality controls and documentation practices.