FDA EIR - Prairie Farms Dairy, Inc. - April 09, 2024

An FDA inspection of Prairie Farms Dairy, Inc. in Fort Wayne, IN, was conducted on April 9, 2024. The inspection focused on Food Good Manufacturing Practices (CGMP), Preventive Controls for Human Food (PCHF), and the Interstate Milk Shippers (IMS) program. Key observations included the firm's inability to provide complete information for two consumer complaints dating from 2019 and 2022 during the current review. Further issues identified required attention to general cleaning throughout the facility. Specific concerns involved the need for proper protection on water push lines, the presence of multiple pumps with compromised seals, and the general condition of floors, ceilings, and walls. Management acknowledged these findings and committed to implementing necessary corrections. The firm's training program, manufacturing codes, and recall procedures, which comply with 21 CFR 117.139, were also reviewed. No samples were collected, and no FDA Form 483 (Inspectional Observations) was issued, indicating that the identified items are considered voluntary corrections to be addressed by the company.