FDA 483 - Legacy Pharmaceutical Packaging LLC - June 30, 2023

Legacy Pharmaceutical Packaging LLC, a drug packager and labeler in Earth City, MO, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate complaints and deviations, lacked scientifically justified and documented cleaning procedures, and did not consistently follow production and process control procedures. Additional issues included inadequate equipment calibration, insufficient line clearance practices, and deficiencies in employee training, indicating a broad lack of adherence to cGMP requirements.