FDA WARNING_LETTER - Red Mill Farms LLC - March 12, 2015

The FDA inspected Red Mill Farms LLC from March 10-12, 2015, identifying significant labeling and Current Good Manufacturing Practice (CGMP) violations. Jennies brand products, promoted online with therapeutic claims, are deemed unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act, violating section 301(d). Multiple products were misbranded under section 403. Village brand Blueberry Macaroons were falsely labeled "nut free" (403(a)(1)) despite containing coconut. Jennies and Village products bore unauthorized nutrient content claims (403(r)(1)(A)), including "healthy," "rich in lauric acid," "best source," "important source," "loaded with Omega-3," "Sugar Free," and "no added sugar," all failing to meet specific regulatory requirements. Nutrition Facts labels were also deficient (403(q)), lacking required fat declarations with "Trans Fat Free" claims and featuring incorrect serving sizes for Village products. The facility's food products were adulterated (402(a)(4)) due to serious CGMP violations (21 CFR Part 110), some repeat offenses. These included failure to protect against contamination (uncovered chocolate equipment), inadequate cleaning (clogged trap, dirty vent, loose ceiling tile, peeling paint), and poorly maintained food contact surfaces and equipment. Red Mill Farms must promptly correct all violations within fifteen working days, providing a detailed response. Non-compliance risks regulatory actions like seizure or injunction, and reinspection fees. Other issues noted were a misleading "Dairy Free" claim and improper declaration of the place of business.