FDA 483 - Jim Bootsma Jr. - July 30, 2021

An FDA inspection conducted at Jim Bootsma Jr., a dairy farm, from July 26 to July 30, 2021, revealed significant compliance deficiencies. The inspection identified four primary observations related to the management of medicated animals, many of which were repeat observations from prior inspections in 2013 and 2016. The farm failed to maintain complete and accurate treatment records for various drugs, including Flunixin Meglumine, Ceftiofur Hydrochloride, Penicillin, and Dexamethasone. These records lacked crucial details such as drug name, dosage, administration route, administering personnel, withdrawal periods, and slaughter dates, as mandated by a Consent Decree of Permanent Injunction (EDCV03 294). Furthermore, the inspection noted that the farm administered Penicillin in dosages exceeding the veterinarian's prescription. An inadequate inventory system for medications was also identified, missing essential information like purchase dates, quantities, strengths, supplier details, administration dates, and amounts. A periodic inventory check, as required by the Consent Decree, was not performed. Finally, Jim Bootsma Jr. failed to systematically review treatment records to ensure proper drug withdrawal periods were observed before animals were offered for slaughter. The farm also did not provide purchasers or consignees with the required written statements certifying that withdrawal periods had expired for medicated animals, nor did it retain copies of signed receipts for these statements. These issues indicate a need for the dairy to establish and implement robust control systems and record-keeping practices in accordance with the existing Consent Decree.