FDA 483 - Lystn, LLC DBA Answers Pet Food - October 04, 2024

Lystn, LLC DBA Answers Pet Food in Elizabethtville, PA, was inspected by the FDA from July to October 2024, resulting in five observations, many of which were repeat findings. The inspection revealed significant issues with the firm's preventive controls for biological and physical hazards, inadequate sanitation practices leading to environmental Listeria monocytogenes contamination, and failures in supplier verification and calibration of critical equipment. The firm also implemented an inappropriate corrective action for a Listeria spp. positive environmental swab.