FDA WARNING_LETTER - EPI, LLC. - November 29, 2010

The FDA inspected EPI, LLC's manufacturing facility in Poplar Grove, Illinois, on multiple dates in November 2010, revealing serious deviations from current Good Manufacturing Practice (cGMP) requirements under 21 CFR Part 110. These conditions rendered the food products adulterated per Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary preparation, packing, or holding. Key violations included the use of unsafe, untested well water and lack of hot water. Plumbing deficiencies were extensive, with sewage spraying in production areas, leaking hoses, lack of backflow prevention, and inadequate floor drainage leading to pooling sewage. Toilet facilities were unsanitary, in disrepair, and lacked proper access and maintenance, with doors opening into food exposure areas. Handwashing facilities were largely absent or non-functional in production areas, lacking running water, drying devices, and instructional signs. Employee hygiene was poor, with observed failures in handwashing, lack of hairnets, and unsuitable outer garments. The facility exhibited significant structural issues, including cracks, holes in windows, dripping condensate, damaged floors, peeling paint, and mold. Pest control was inadequate, evidenced by rodent excreta, bugs, missing screens, and overgrown exterior vegetation. Equipment was deteriorated, not corrosion-resistant, and not easily cleanable. Furthermore, production procedures contributed to contamination, and finished food was improperly stored, including in toilet facilities. The firm also lacked competent supervisory personnel trained in food sanitation. EPI, LLC is required to promptly correct all violations, provide a written response within 15 working days detailing corrective actions, a prevention plan, and a timetable. Failure to comply may lead to legal action, including seizure and injunction.