FDA WARNING_LETTER - Kwokcheng Enterprise, Inc. dba Fullei Fresh - March 11, 2019

The FDA inspected a sprouting operation in Miami, FL, from January 28 to March 11, 2019, identifying serious violations of the Produce Safety regulation (21 CFR Part 112). Environmental samples tested positive for *Listeria monocytogenes* (L. mono), a human pathogen, including on food contact surfaces. Product samples of organic bean sprouts also tested positive for L. mono. These findings render the products adulterated under Sections 402(a)(4) and 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, and failure to comply with the Produce Safety regulation is a prohibited act under Section 301(vv).

Whole genome sequencing (WGS) analysis linked the L. mono strains from FDA environmental samples to those found in bean sprout samples collected by the Florida Department of Agriculture and Consumer Services (FDACS), indicating a common source and inadequate sanitation.

Specific violations of 21 CFR Part 112 include: 1. Failure to conduct additional sampling and testing to eliminate L. mono after positive results, and failure to prevent recurrence (21 CFR 112.146(c) and (e)). Repeated positive findings on the bean sprout packing table demonstrate recurrence. 2. Failure to inspect, maintain, clean, and sanitize food contact surfaces of equipment and tools as frequently as necessary (21 CFR 112