FDA WARNING_LETTER - Ian's Natural Foods, Inc - September 21, 2010

The FDA issued a Warning Letter to Ian’s Natural Foods, Inc. following inspections from May to September 2010 at their Framingham, MA facility. A finished frozen food product, Ian’s Egg & Maple Cheddar Wafflewich Wheat Free/Gluten Free Breakfast Sandwich, was found to be adulterated under 21 U.S.C. § 342(a)(1) due to the presence of Listeria monocytogenes. The inspections also revealed significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110, leading to adulterated food under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Specific CGMP deficiencies included employees failing to conform to hygienic practices (21 CFR 110.10(b)). On September 2, 2010, an employee moved between raw product, finished product, and washroom areas without hand washing. On September 3, 2010, another employee handled bread crumbs with an ungloved hand after climbing a ladder. The FDA emphasized the need to identify and control L. monocytogenes niche areas, implement effective environmental monitoring, and intensify cleaning. The firm's October 21, 2010, response was deemed insufficient, lacking details on reassessing their Listeria monitoring program. The firm verbally committed to discontinuing ready-to-eat product manufacturing, for which written confirmation was requested. Ian's Natural Foods must provide a written response within 15 working days detailing corrective actions, prevention plans, and a timetable for completion to avoid further legal action.