FDA WARNING_LETTER - Louie Foods International - February 28, 2017

On August 21, 2017, the FDA issued a Warning Letter to Louie Foods International following an inspection from February 13-28, 2017. The inspection revealed that alfalfa and mung bean sprouts, noodles, and wonton wrappers were adulterated under 21 U.S.C. 342(a)(4) due to insanitary conditions.

Key violations in the sprout operation included: water splashing from floors onto sprouts during cleaning, sprouts in direct contact with soiled pallets, employees handling sprouts with unwashed hands after touching insanitary objects, and inadequate handwashing facilities (no soap/paper towels, brown/cold water, fecal matter in toilet, no toilet paper).

CGMP violations for processed foods (noodles, wonton wrappers) included: failure to exclude pests (rodent excreta, dead insects near packaging), bird droppings on noodle packaging with birds flying overhead, and employees not conforming to hygienic practices (uncovered mustaches, exposed bandage on finger handling noodles).

The FDA acknowledged the firm's March 21, 2017 response but deemed it inadequate due to a lack of supporting documentation. The letter also noted the detection of *Listeria monocytogenes* in environmental samples from the cooler and observed employees entering the sprout de-hulling/packing room without sanitizing footwear, with the foot bath testing below effective levels.

Louie Foods International was required to respond within fifteen