FDA WARNING_LETTER - Good Seed, Inc. - June 03, 2015

The FDA conducted an inspection of Good Seed, Inc.'s soybean and mung bean sprout growing and packaging operation in Springfield, VA, from June 1-3, 2015. Environmental swabs collected during the inspection tested positive for *Listeria monocytogenes* (L. monocytogenes), a human pathogen. FDA investigators observed food particles on a bagging machine's hopper and conveyor belt, which had been cleaned the day prior; a swab from this location yielded *L. monocytogenes*. The Virginia Department of Agriculture and Consumer Services (VDACS) also collected finished product samples that yielded a strain of *L. monocytogenes* indistinguishable from the environmental strain.

These findings indicate that *L. monocytogenes* from the environment may have contaminated the product, rendering the sprouts adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to being prepared, packed, or held under insanitary conditions.

Good Seed, Inc.'s June 15, 2015, 483 response, acknowledging removal of food particles and plans for thorough cleaning, was deemed insufficient. The response lacked details on the specific sanitizer used, its application method, and whether extensive cleaning involved disassembling or replacing machinery parts.

The FDA requires a written response within fifteen working days outlining specific corrective actions, including pertinent photography or other useful information. If corrections cannot be completed, an explanation for the