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

The FDA inspected Good Seed, Inc.'s sprout facility from June 1-3, 2015, and found serious violations. Environmental samples tested positive for *Listeria monocytogenes* on a food-contact surface of a sprout bagging machine. This strain matched *Listeria* found in Virginia Department of Agriculture and Consumer Services (VDACS) product samples. This indicates inadequate sanitation and adulterated food products under 21 U.S.C. § 342(a)(4).

Good Seed, Inc. failed to report three voluntary recalls of soybean and mung bean sprouts due to *Listeria* contamination to the Reportable Food Registry (RFR) within 24 hours, a violation of 21 U.S.C. § 350f(d)(1) and a prohibited act under 21 U.S.C. § 331(mm).

Additionally, the inspection revealed a Current Good Manufacturing Practice (CGMP) violation (21 CFR 110.35(d)) for failing to adequately clean food-contact surfaces. Food particles were observed on a bagging machine's hopper and conveyor belt, which had been cleaned the previous day, directly where the *Listeria* positive sample was collected.

The firm's June 15, 2015, response to the FDA Form 483 was deemed insufficient as it lacked specific details on