The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Chang and Son Enterprises Inc.
Whately, MA
The FDA has warned a food firm in Massachesseutts after testing of their mung bean sprouts at the company’s sprouting operation and at retailers found Listeria monocytogenes.
The FDA analyzed an environmental sample, which consisted of 15 environmental swabs collected on Dec. 20, 2023, from Chang and Son Enterprises Inc.’s sprouting operation in 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.
Based on the FDA’s analysis of the environmental samples, the FDA has determined that the firm’s mung bean and soybean sprouts are adulterated 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, the FDA determined that the isolates from this sample match each other and 10 other Listeria monocytogenes that were isolated from several product samples collected from April 23, 2023, through Dec. 4, 2023.
Based on this evaluation, the FDA has determined that the firm’s mung bean sprouts are contaminated in that they contain a poisonous or deleterious substance which may render them injurious to health.
Pathogen Findings
Listeria 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 Listeria 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 Dec. 20, 2023, confirmed that two of the fifteen swabs were positive for Listeria monocytogenes. FDA also conducted WGS analysis on the environmental swabs taken by MDAR on Dec. 20, 2023, and on the following samples of the firm’s 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 (redacted by FDA), analyzed at the NYSAGM Division of Food Laboratory, and tested positive for Listeria monocytogenes.
b. On May 4, 2023, MDAR conducted an inspection of the firm’s 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 Listeria monocytogenes.
c. On Dec. 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 (redacted by FDA). Sample was analyzed by the VDACS Division of Consolidated Laboratory Services and tested positive for Listeria 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 Listeria monocytogenes in the firm’s operation is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens in their operation to prevent contamination of food.
The full warning letter can be viewed here.
Ng Zheng Inc. DBA Kwan Sang Noodle Company
Denver, CO
The FDA has warned a food firm in Colorado over various violations of the Hazard Analysis and Risk-Based Preventive Controls and Current Good Manufacturing Practice regulations, including cockroaches in their facility.
In an April 23, 2024, warning letter, the FDA described a Sept. 18 – Oct. 23, 2023, inspection of Ng Zheng Inc.’s manufacturing facility in Denver, CO.
The FDA’s inspection revealed that the firm was not in compliance with federal regulations, which resulted in the issuance of an FDA Form 483.
Some of the significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls
1. The firm did not conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for their non-RTE egg roll wrappers, wonton wrappers, dumpling wrappers, fresh flour noodles, and fresh egg noodles, as required. Specifically, the facility’s written hazard analysis for their non-RTE products did not consider undeclared allergens as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. The firm manufactures various products that contain allergens (such as wheat and egg). Therefore, undeclared allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring that all food allergens required to be stated are included on the label.
2. The firm did not implement their preventive control procedures to provide assurances that the hazard of allergen cross-contact will be significantly minimized or prevented as required.
They manufacture their non-RTE fresh egg noodles containing egg allergen on equipment also used to manufacture other products such as non-RTE wonton and dumpling wrappers that do not contain egg allergen. The firm’s Food Safety Plan states “After egg noodles are made, machines are both disinfected and sanitized before other products are made.” Under the “Sanitation Preventive Controls” section of their Food Safety Plan, it states cleaning is to occur “(redacted by FDA) after egg noodles are made.” However, they did not implement their procedure that states “Manager on shift will come by and checked [sic] everything is cleaned properly and signed [sic] sanitation records.” They were unable to provide any monitoring records to demonstrate their preventive control for the hazard of allergen cross-contact is consistently performed.
The firm processes dough for non-RTE egg noodles, which is yellow in color, as the last product of the production day and conduct cleaning of shared equipment prior to the start of production for products not containing egg. FDA notes that they do not have adequate controls in place for allergen cross-contact as evidenced by the following observations made on Sept. 22, 2023, after cleaning of shared pieces of equipment:
a. The firm’s “Dough Mixer (redacted by FDA)” was observed with apparent food product residue on the food-contact surfaces of the mixer blades, interior wall surfaces, and bolts.
b. The firm’s “Dough Folder (redacted by FDA)” was observed with apparent egg dough residue on the following food-contact surfaces:
i. Between the bolted-on cutting board surfaces at the exit of the large dough breaker drum,
ii. On both sides of the dough mixer where the protective barriers meet the food contact side of the cutting boards, and
iii. On the scarred surfaces of the plastic white cutting boards attached to the dough breaker.
c. The firm’s “Dough Folder (redacted by FDA)” was observed with apparent egg dough residue on the food-contact surfaces between the bolted-on cutting board surfaces at the exit of the large dough breaker drum.
d. The firms noodle cutting machine was observed with apparent egg dough residue on the food-contact surfaces.
3. The firm did not conduct a hazard analysis for each type of food manufactured, processed, packed or held at their facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required. They have not conducted a hazard analysis that covers RTE noodles manufactured by their firm (i.e., steamed flour noodles, steamed egg noodles, and fried noodles).
a. The firm’s facility manufactures RTE steamed egg noodles, RTE steamed flour noodles, and RTE fried noodles, which are exposed to the environment after cooking and prior to packaging. Their employees hand-pack the food, and the packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens at the packaging step. A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens such as Salmonella spp. or Listeria monocytogenes, as a known or reasonably foreseeable hazard requiring a preventive control. Furthermore, the firm does not monitor sanitation or conduct environmental monitoring.
Sanitation controls include procedures, practices and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling. In addition, environmental monitoring is required if contamination of a RTE food with an environmental pathogen is a hazard requiring a preventive control. They are also required to establish and implement an environmental monitoring written procedure.
The firm has a written sanitation procedure under the “Sanitation Preventive Controls” section of their Food Safety Plan for their non RTE products. However, this procedure states the purpose is to “Clean food allergen (egg products) before making new products.” The list of equipment under “Location” does not include equipment and areas of their facility where RTE steamed egg noodles, RTE steamed flour noodles and RTE fried noodles are also at risk of contamination with pathogens due to employee handling.
In addition, the following observations were made on Sept. 19, 2023 during production:
i. An employee was observed using their gloved hands to pack RTE steamed flour noodles and RTE steamed egg noodles into plastic bags. The employee momentarily stopped hand packing the RTE noodles and was observed touching non-food contact surfaces (e.g., cardboard boxes and doorknobs). The employee then returned to the station and resumed hand packing the RTE steamed flour noodles without first washing or sanitizing their hands or changing their gloves. In addition, the same employee was observed touching the inside of the plastic bags (food-contact surface) at the time they resumed packing the RTE steamed flour noodles.
ii. An employee was observed using their gloved hands to pack RTE steamed egg noodles into plastic bags. The same employee was observed handling cardboard and then returning to hand pack the RTE noodles without first washing or sanitizing their hands or changing their gloves.
4. The firm’s written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented, as required. Specifically, their hazard analysis for their non-RTE food products appropriately identified mycotoxins hazard for their wheat flour which is used in every product manufactured by their firm as a hazard requiring a preventive control. Their hazard analysis indicates that this hazard is controlled by their supplier by obtaining a Certificate of Analysis (COA) to confirm. However, the firm was not reviewing COAs.
Current Good Manufacturing Practice
1. The firm did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contamination and against contamination of food, as required. Specifically,
a. On Sept. 19, 2023, an employee was leaning over a stainless-steel table where exposed RTE steamed egg noodles were left to cool after being steamed. The employee’s visibly soiled apron made contact with the exposed RTE noodles.
b. On Sept. 19, 2023, an employee was using visibly soiled towels to retrieve steamed RTE steamed egg noodles trays from the steamer. The soiled towels came into contact with the RTE steamed egg noodles.
c. On Sept. 18 and 19, 2023, multiple employees were observed using their entire bare forearms to manipulate dough sheets. These employees did not wash their forearms or don disposable arm sleeves prior to handling the dough sheets with their bare forearms.
d. On Sept. 19, 2023, RTE steamed egg noodles were spread out over a stainless-steel table to cool. These RTE noodles were observed coming into contact with an adjacent stainless-steel table visibly covered with apparent dust.
2. The firm did not provide adequate space for such placement of equipment as is necessary for maintenance, sanitary operations and the production of safe food, as required. Specifically, stainless steel tables where RTE noodles are placed to cool in their steam room are positioned directly against the wall allowing RTE steamed noodles to come into contact with the wall. Further, a wall observed coming into contact with the RTE noodles on the stainless-steel table was visibly unclean.
3. The firm did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required. Specifically,
a. On Sept. 18, 2023, one dead apparent cockroach was observed in the production room behind the inoperable “Dough Mixer (redacted by FDA)” and next to a storage container containing corn starch being use for the manufacturing of fried wonton dough.
b. On Sept. 18, 2023, three dead apparent cockroaches were observed inside the three-compartment sink beside where noodles were being fried. One dead apparent cockroach was also observed under the three-compartment sink. On Sept. 22, 2023, three dead apparent cockroaches and one live apparent cockroach were observed inside the same three-compartment sink.
c. On Sept. 19, 2023, one dead apparent cockroach was observed in the drain located between the frying station and the cooling table located inside the frying room where fried noodles are manufactured.
4. The firm did not maintain buildings, fixtures, and other physical facilities of their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, floors throughout the production and packing rooms, including areas where RTE foods are processed/packed, were cracked, pitted and chipped during the FDA walk-through on Sept. 18, 2023.
The full warning letter can be viewed here.
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