FDA EIR - Bio Agri Mix LP - July 22, 2016

An FDA inspection of Bio Agri Mix LP (BAM) was conducted from July 18-22, 2016, as a comprehensive Vet Drug GMP and Type A Medicated Articles assessment. The inspection followed regulatory guidelines CP 7371.001 and CP 7371.005, focusing on animal drug manufacturing. The inspection identified two main observations, documented on a Form FDA 483. First, the facility's buildings, specifically in Type A Medicated production areas, exhibited inadequate environmental controls. Issues included significant dust, debris, and rejected material on equipment and floors, improper storage of unlabeled substances, uncovered raw materials on pallets, and exposed insulation near manufacturing zones. These conditions presented contamination risks. Second, laboratory controls were found deficient. The company failed to initiate manufacturing investigations for low packaging yield failures and repeated confirmed stability failures of Type A medicated articles. Furthermore, prior investigations into out-of-specification assays for multiple lots were incomplete, lacking assessments of validation and stability studies. In response, Bio Agri Mix LP management, led by Chairman Paul Lake, committed to immediate corrective actions for all identified issues. They also pledged to submit a detailed written response to the Center for Veterinary Medicine (CVM) within 15 to 30 working days, outlining their remedial plans.