Midwest Northem, Inc. – FDA Warning Letter, Dec 14, 2011

The FDA inspected Midwest Northern, Inc.'s manufacturing facility in Minneapolis, MN, on December 7-8 and 14, 2011, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These deficiencies render the firm's food products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. Key violations included the failure to handle work-in-process to prevent contamination, specifically allergen cross-contact during roasting of different nuts and seeds. The firm also failed to adequately clean and sanitize utensils and equipment, particularly a grated chain link conveyor belt, between production runs, leading to debris and potential cross-contact. Further issues involved employees consuming food and beverages in areas where food was exposed, dirty fans blowing onto products, employees wearing unsecured jewelry that could fall into food, and inadequate pest protection due to gaps in loading doors. Midwest Northern, Inc. is required to take prompt corrective action and submit a written response to the FDA within 15 working days, detailing specific steps taken or a timeline for completion. Failure to correct these violations may result in regulatory actions such as product seizure or injunction, and the firm may be assessed re-inspection fees.