FDA WARNING_LETTER - Chang and Son Enterprises, Inc. - February 08, 2024
On May 31, 2024, the FDA issued a Warning Letter to Mr. Chang, following an analysis of environmental samples collected on December 20, 2023, by the Commonwealth of Massachusetts Department of Agricultural Resources (MDAR) from a sprouting operation at 301 River Road, Whately, MA. Two of fifteen environmental swabs tested positive for *Listeria monocytogenes* (*L. monocytogenes*).
The FDA determined that the mung bean and soybean sprouts were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), due to insanitary conditions. Whole Genome Sequence (WGS) analysis revealed that isolates from the December 20, 2023, environmental sample matched ten other *L. monocytogenes* isolates from product samples collected between April 23, 2023, and December 4, 2023. This led to a determination that mung bean sprouts were contaminated under section 402(a)(1) of the Act, 21 U.S.C. § 342(a)(1), containing a poisonous or deleterious substance.
Previous positive findings of *L. monocytogenes* in mung bean sprouts were identified on April 24,
ID · 5b6579d6-7e8e-4b52-a4d0-ffa53541bd2a
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