USA- FDA Warning Letter – Chang and Son Enterprises, Inc. – Listeria monocytogenes

FDA

The United States Food and Drug Administration (FDA) analyzed the environmental sample identified as sample 1245959, which consisted of 15 environmental swabs collected on December 20, 2023, from your sprouting operation at 301 River Road, Whately, MA, by the Commonwealth of Massachusetts Department of Agricultural Resources (MDAR) and determined that two of the fifteen swabs were positive for the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen. Based on FDA’s analysis of the environmental samples, we have determined that your mung bean and soybean sprouts are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Additionally, based on evaluation of whole genome sequence (WGS) analysis, we determined that the isolates from sample 1245959 match each other and 10 other L. monocytogenes that were isolated from several product samples collected from April 23, 2023, through December 4, 2023.