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

An FDA inspection of Bio Agri Mix LP, a contract manufacturer of animal drugs and Type A Medicated Articles, was conducted from July 18-22, 2016. The inspection, carried out under FDA's Center for Veterinary Medicine (CVM) regulations for Veterinary Drug Good Manufacturing Practices (GMP) and Type A Medicated Articles, identified two main areas of concern. Firstly, the facility's buildings, specifically a production area for Type A Medicated articles, were cited for inadequate environmental controls, including insufficient lighting, ventilation, and dust control. Specific observations included significant dust and debris on critical equipment and the floor, an unlabeled oily component stored improperly, exposed raw materials on a pallet, and visible exposed insulation within core manufacturing areas. These conditions indicate a risk of contamination. Secondly, the inspection found deficiencies in the company’s laboratory controls and investigation procedures. The firm failed to initiate comprehensive manufacturing investigations for instances of low packaging yields and confirmed product stability failures. Furthermore, investigations into repeated out-of-specification assay results were incomplete, lacking an assessment of relevant validation and stability studies. In response, Bio Agri Mix LP's Chairman, Paul Lake, committed to taking immediate corrective actions and pledged to submit a detailed written response to CVM within 15 to 30 working days.