FDA WARNING_LETTER - Henrys Farm Inc. - May 10, 2012

The FDA inspected Henry's Farm Inc.'s soybean and mung-bean sprout facility from April 30 to May 10, 2012, following a Virginia Department of Agriculture and Consumer Services (VDACS) sample that yielded *Listeria monocytogenes*. FDA's own samples confirmed *Listeria monocytogenes* in JJBS soybean sprouts. The company recalled products, ceased production, and disposed of in-process items.

The facility's soybean and mung-bean sprouts were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Observed violations included: numerous rodent pellets and gnawing in seed storage areas, with gaps under doors and holes in ceilings allowing pest ingress; a hand-washing sink draining onto the floor, potentially spreading pathogens; accumulation of debris on food contact surfaces and conveyor belts, with no detergent used for cleaning; and loose metal burrs on a conveyor belt without subsequent metal detection.

Additionally, JJBS soybean sprouts and mung-bean sprouts were misbranded under Section 403 of the Act because labels lacked a statement of identity (21 CFR 101.3), the name and place of business of the manufacturer/packer/distributor (21 CFR 101.5), and an accurate net quantity of contents (21 CFR 101.105).

Henry