# FDA WARNING_LETTER - Chang and Son Enterprises, Inc. - February 08, 2024

Source: https://www.keypedia.com/records/warning_letter/chang-and-son-enterprises-inc/5b6579d6-7e8e-4b52-a4d0-ffa53541bd2a

> FDA WARNING_LETTER for Chang and Son Enterprises, Inc. on February 08, 2024. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Chang and Son Enterprises, Inc.
- Inspection Date: 2024-02-08
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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,

## Related Officers

- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/chang-and-son-enterprises-inc/082a82d0-df7a-43e4-bc5b-0eaf82b231d3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961