FDA WARNING_LETTER - Sun Hang Bean Sprout Inc - October 16, 2009

On September 25-October 16, 2009, the FDA inspected Sun Hang Bean Sprout, Inc.'s facility in Detroit, Michigan, and documented significant insanitary conditions. Analysis of environmental swabs also found Listeria monocytogenes (L. monocytogenes), leading to the determination that the mung bean sprouts were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations included: employees dragging perforated barrels of sprouts on wet, sewage-contacted floors without sanitization; an employee using a soiled boot to stop a centrifuge containing sprouts; cross-contamination from stacking soiled barrels; over 100 rodent excreta pellets and nesting observed; German cockroaches observed near processing equipment; brownish-black build-up on food-contact surfaces of shovels and processing machines; employees not washing or sanitizing hands before handling sprouts; and condensation dripping onto sprouts and sprouts stored in standing water in refrigerators.

L. monocytogenes was found on a pallet under the sprout centrifuge. The FDA noted that these conditions could lead to pathogen contamination and growth. The company verbally committed to cleaning, creating a cleaning schedule, and employee hygiene education, which will be verified. The firm must respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation. Failure to comply may result in product seizure or injunction.