FDA WARNING_LETTER - Alfred Louie Inc - October 10, 2012

On February 21, 2013, the FDA issued a Warning Letter to Alfred Louie, Inc. following an inspection from September 19 to October 10, 2012, at their Bakersfield, California facility. The inspection found that mung bean and soybean sprouts, along with refrigerated noodles, cashews, rice, teas, paprika, pepper, and cooked frozen ducks, were adulterated under 21 U.S.C. 342(a)(4) due to insanitary conditions.

Key violations included: - **Insanitary Conditions and Practices:** Employees handled sprouts with bare, unwashed hands after restroom breaks or operating forklifts, lacking a hand-washing facility in the sprout production room. An employee used unsanitized rubber boots to turn a wheel contacting sprouts. Organic and sprout residues were found on packing equipment after cleanup. Standing water and organic matter were on the pitted sprout production floor. An electrical cord with brown liquid in a plastic bag contacted in-process sprouts. Open sprout bags were stored in unclean, reused wooden crates. - **CGMP Violations (21 CFR Part 110):** - Failure to exclude pests (21 CFR 110.35(c)): Rodent gnaw holes in product boxes, rodent excreta, a dead mouse, and live flies were observed. Rodent bait boxes with exposed food contact surfaces and containers of rodent poison were improperly