WARNING LETTER
Chang and Son Enterprises, Inc.
MARCS-CMS 679517 —
May 31, 2024
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Sidney Chang
Recipient Title
President
Chang and Son Enterprises, Inc.
301 River Road
Whately
,
MA
01093
United States
Issuing Office:
Division of Human and Animal Food Operations East I
United States
WARNING LETTER
CMS # 679517
5/31/2024
Dear Mr. Chang,
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.
Based on this evaluation, we have determined that your mung bean sprouts are contaminated within the meaning of section 402(a)(1) of the Act, 21 U.S.C. § 342(a)(1), in that they contain a poisonous or deleterious substance which may render them injurious to health. You can find the Act and its implementing regulations through internet links in FDA's home page at http://www.fda.gov.
Pathogen Findings
L. monocytogenes
is a pathogenic bacterium that is widespread in the environment and may be introduced into a sprouting operation from raw materials, humans, or equipment. Without proper sanitation practices, it can proliferate in a sprouting operation where it may contaminate food. Consuming food contaminated with
L. monocytogenes
can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.
FDA’s analysis of the environmental swabs collected by MDAR on December 20, 2023, confirmed that two of the fifteen swabs were positive for
L. monocytogenes
. FDA also conducted WGS analysis on the environmental swabs taken by MDAR on December 20, 2023, and on the following samples of your mung bean sprouts:
a. On April 24, 2023, New York State - Agriculture and Markets (NYSAGM) Division of Food Safety and Inspection collected a sample of mung bean sprouts identified as sample: FL No. 2339630013 / Lab No. 23B04362. The sample was collected at a retail store located in
(b)(4)
, analyzed at the NYSAGM Division of Food Laboratory, and tested positive for
L. monocytogenes
.
b. On May 4, 2023, MDAR conducted an inspection of your sprout operation and collected a sample of mung bean sprouts identified as Event Code: 05042023/Lab #: 23EN2354. The sample was analyzed by Massachusetts State Public Health Laboratory, and the sample tested positive for the human pathogen
L. monocytogenes
.
c. On December 4, 2023, Virginia Department of Agriculture and Consumer Services (VDACS) Food Safety Program collected a sample of mung bean sprouts identified as sample: E231200179 (VDACS ID 992007932). This sample collected as part of the FDA/State Laboratory Flexible Funding Model (LFFM) sampling program and was collected at a retail supermarket located in
(b)(4)
. Sample was analyzed by the VDACS Division of Consolidated Laboratory Services and tested positive for
L. monocytogenes
.
WGS analysis of bacterial human pathogens provides high-resolution data as it measures each DNA position in a bacterial genome, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. The WGS data can also be used to infer the evolutionary relationships (or phylogeny) of a given set of isolates. Six isolates identified in environmental sample 1245959 were found to match each other. These six isolates also matched ten isolates identified in the three product samples listed in the above descriptions, sample: FL No. 2339630013 / Lab No. 23B04362, Event Code: 05042023/Lab #: 23EN2354, and E231200179 (VDACS ID 992007932). The high genetic similarity of the sixteen isolates and that they belong to the same strain suggests they likely came from the same source. The presence of
L. monocytogenes
in your operation is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your operation to prevent contamination of food.
We acknowledge that you initiated a recall on May 9, 2023, in response to the positive
L. monocytogenes
findings from MDAR from samples of your product collected on May 4, 2023, and that you initiated a recall on December 15, 2023 in response to the positive
L. monocytogenes
findings from VDACS from samples of your product collected on December 4, 2023.
In response to the above findings, FDA conducted an inspection of your sprouting operation located at 301 River Road., Whatley, Massachusetts, from January 10, 2024, through February 8, 2024, in accordance with Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (the Produce Safety Rule or PSR), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112). We collected 91 environmental swabs, one of which, a sample from the bed of a truck outside your operation, yielded
L. monocytogenes
. At the close of the inspection, the FDA investigators issued your operation a Form FDA 483 (FDA-483), Inspectional Observations.
We acknowledge your written response to the FDA-483, received February 20, 2024. You stated that you have taken various corrective actions, including holding an employee meeting on the importance of following various sanitary practices, appointing an employee to monitor employee practices, informing your laboratories of discrepancies, and establishing processes with your laboratory regarding reporting sample discrepancies, sample issues, sending alternate samples, and checking results. You also explained various standard operating procedures and their updates at your facility, as well as the re-training of employees. We will ascertain the adequacy of your corrections in our next inspection.
We note that despite our positive findings of
Listeria
in your environment, your records show that you have not been able to find
Listeria
in your environment. We recommend that you review your
Listeria
monitoring plan, including the frequency and methodology of testing to find out why you have not been able to find
Listeria
in your environment. We also recommend that you review your cleaning frequency and methods to make sure your cleaning is adequate to control
Listeria
in your environment.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence of the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or
(b)(3)(A)
if criteria and conditions warrant.
Please notify this office in writing within 15 working days of the receipt of this letter, as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433 or via email at Lillian.aveta@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or email at Lillian.aveta@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
06/18/2024
Regulated Product(s)
Food & Beverages