FDA 483 - AGCO Hay LLC - April 04, 2024

An FDA inspection of AGCO Hay LLC, a beef cattle ranch, was conducted from April 2-4, 2024, resulting in a Form 483 listing significant observations. The primary issue involved an extralabel use of an approved drug, oxytetracycline, leading to residues in a beef cow beyond established safe levels. Specifically, tests revealed oxytetracycline at 2.84 ppm in muscle and 35.2 ppm in kidney, exceeding the regulatory tolerances of 2.00 ppm and 12.00 ppm, respectively. This indicates a failure to ensure food safety standards for human consumption. A second critical observation concerned inadequate medication treatment records. The company failed to record treatment for a culled beef cow sent for slaughter. Furthermore, existing records were incomplete, lacking crucial details such as the route of administration, the individual administering medication, the condition being treated, the specified meat/slaughter withdrawal period, and the date the withdrawal period was observed. These record-keeping deficiencies hinder proper tracking and verification of drug use, impacting public health safeguards. These observations highlight non-compliance with regulations under the Federal Food, Drug, and Cosmetic Act, particularly concerning drug residue prevention and accurate documentation in food-producing animals. AGCO Hay LLC is required to respond to these findings, outlining implemented or planned corrective actions to address the identified issues and prevent recurrence.