The Meals and Drug Administration sends warning letters to entities below its jurisdiction as a part of its enforcement actions. Some letters are usually not posted for public view till weeks or months after they’re despatched. Enterprise house owners have 15 days to answer FDA warning letters. Warning letters usually are usually not issued till an organization has been given months to years to right issues.
Chang and Son Enterprises Inc.
Whately, MA
The FDA has warned a meals agency in Massachesseutts after testing of their mung bean sprouts on the firm’s sprouting operation and at retailers discovered Listeria monocytogenes.
The FDA analyzed an environmental pattern, 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 Division of Agricultural Sources (MDAR) and decided that two of the fifteen swabs have been constructive for the presence of Listeria monocytogenes.
Primarily based on the FDA’s evaluation of the environmental samples, the FDA has decided that the agency’s mung bean and soybean sprouts are adulterated in that they’ve been ready, packed, or held below insanitary situations whereby they could have been rendered injurious to well being. Moreover, primarily based on analysis of complete genome sequence (WGS) evaluation, the FDA decided that the isolates from this pattern match one another and 10 different Listeria monocytogenes that have been remoted from a number of product samples collected from April 23, 2023, by Dec. 4, 2023.
Primarily based on this analysis, the FDA has decided that the agency’s mung bean sprouts are contaminated in that they comprise a toxic or deleterious substance which can render them injurious to well being.
Pathogen Findings
Listeria monocytogenes is a pathogenic bacterium that’s widespread within the atmosphere and could also be launched right into a sprouting operation from uncooked supplies, people or tools. With out correct sanitation practices, it may possibly proliferate in a sprouting operation the place it could contaminate meals. Consuming meals contaminated with Listeria monocytogenes can result in a extreme, typically life-threatening sickness known as listeriosis, a foodborne sickness, which is a significant public well being concern because of the severity of the illness, its excessive case-fatality price, lengthy incubation time, and tendency to have an effect on people with underlying situations.
FDA’s evaluation of the environmental swabs collected by MDAR on Dec. 20, 2023, confirmed that two of the fifteen swabs have been constructive for Listeria monocytogenes. FDA additionally performed WGS evaluation on the environmental swabs taken by MDAR on Dec. 20, 2023, and on the next samples of the agency’s mung bean sprouts:
a. On April 24, 2023, New York State – Agriculture and Markets (NYSAGM) Division of Meals Security and Inspection collected a pattern of mung bean sprouts recognized as pattern: FL No. 2339630013 / Lab No. 23B04362. The pattern was collected at a retail retailer situated in (redacted by FDA), analyzed on the NYSAGM Division of Meals Laboratory, and examined constructive for Listeria monocytogenes.
b. On Could 4, 2023, MDAR performed an inspection of the agency’s sprout operation and picked up a pattern of mung bean sprouts recognized as Occasion Code: 05042023/Lab #: 23EN2354. The pattern was analyzed by Massachusetts State Public Well being Laboratory, and the pattern examined constructive for the human pathogen Listeria monocytogenes.
c. On Dec. 4, 2023, Virginia Division of Agriculture and Client Companies (VDACS) Meals Security Program collected a pattern of mung bean sprouts recognized as pattern: E231200179 (VDACS ID 992007932). This pattern collected as a part of the FDA/State Laboratory Versatile Funding Mannequin (LFFM) sampling program and was collected at a retail grocery store situated in (redacted by FDA). Pattern was analyzed by the VDACS Division of Consolidated Laboratory Companies and examined constructive for Listeria monocytogenes.
WGS evaluation of bacterial human pathogens gives high-resolution information because it measures every DNA place in a bacterial genome, enabling direct hyperlinks to be established between scientific isolates and meals or environmental sources of bacterial contamination and sickness. The WGS information will also be used to deduce the evolutionary relationships (or phylogeny) of a given set of isolates.
Six isolates recognized in environmental pattern 1245959 have been discovered to match one another. These six isolates additionally matched ten isolates recognized within the three product samples listed within the above descriptions, pattern: FL No. 2339630013 / Lab No. 23B04362, Occasion Code: 05042023/Lab #: 23EN2354, and E231200179 (VDACS ID 992007932). The excessive genetic similarity of the sixteen isolates and that they belong to the identical pressure suggests they seemingly got here from the identical supply. The presence of Listeria monocytogenes within the agency’s operation is important in that it demonstrates their sanitation efforts are insufficient to successfully management pathogens of their operation to forestall contamination of meals.
The complete warning letter may be considered here.
Ng Zheng Inc. DBA Kwan Sang Noodle Firm
Denver, CO
The FDA has warned a meals agency in Colorado over varied violations of the Hazard Evaluation and Danger-Primarily based Preventive Controls and Present Good Manufacturing Observe laws, together with cockroaches of 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 agency was not in compliance with federal laws, which resulted within the issuance of an FDA Type 483.
A number of the vital violations are as follows:
Hazard Evaluation and Danger-Primarily based Preventive Controls
1. The agency didn’t conduct a hazard evaluation to establish and consider a recognized or moderately foreseeable hazard to find out whether or not it required a preventive management for his or her non-RTE egg roll wrappers, wonton wrappers, dumpling wrappers, recent flour noodles, and recent egg noodles, as required. Particularly, the power’s written hazard evaluation for his or her non-RTE merchandise didn’t take into account undeclared allergens as a recognized or moderately foreseeable hazard to find out whether or not it’s a hazard requiring a preventive management. The agency manufactures varied merchandise that comprise allergens (similar to wheat and egg). Due to this fact, undeclared allergens are a recognized or moderately foreseeable hazard. A educated individual manufacturing/processing meals of their circumstances would establish allergens as a hazard requiring a preventive management. Meals allergen controls embrace procedures, practices, and processes employed for making certain that each one meals allergens required to be said are included on the label.
2. The agency didn’t implement their preventive management procedures to offer assurances that the hazard of allergen cross-contact shall be considerably minimized or prevented as required.
They manufacture their non-RTE recent egg noodles containing egg allergen on tools additionally used to fabricate different merchandise similar to non-RTE wonton and dumpling wrappers that don’t comprise egg allergen. The agency’s Meals Security Plan states “After egg noodles are made, machines are each disinfected and sanitized earlier than different merchandise are made.” Underneath the “Sanitation Preventive Controls” part of their Meals Security Plan, it states cleansing is to happen “(redacted by FDA) after egg noodles are made.” Nonetheless, they didn’t implement their process that states “Supervisor on shift will come by and checked [sic] the whole lot is cleaned correctly and signed [sic] sanitation data.” They have been unable to offer any monitoring data to display their preventive management for the hazard of allergen cross-contact is persistently carried out.
The agency processes dough for non-RTE egg noodles, which is yellow in coloration, because the final product of the manufacturing day and conduct cleansing of shared tools previous to the beginning of manufacturing for merchandise not containing egg. FDA notes that they don’t have satisfactory controls in place for allergen cross-contact as evidenced by the next observations made on Sept. 22, 2023, after cleansing of shared items of apparatus:
a. The agency’s “Dough Mixer (redacted by FDA)” was noticed with obvious meals product residue on the food-contact surfaces of the mixer blades, inside wall surfaces, and bolts.
b. The agency’s “Dough Folder (redacted by FDA)” was noticed with obvious egg dough residue on the next food-contact surfaces:
i. Between the bolted-on slicing board surfaces on the exit of the big dough breaker drum,
ii. On each side of the dough mixer the place the protecting limitations meet the meals contact aspect of the slicing boards, and
iii. On the scarred surfaces of the plastic white slicing boards connected to the dough breaker.
c. The agency’s “Dough Folder (redacted by FDA)” was noticed with obvious egg dough residue on the food-contact surfaces between the bolted-on slicing board surfaces on the exit of the big dough breaker drum.
d. The corporations noodle slicing machine was noticed with obvious egg dough residue on the food-contact surfaces.
3. The agency didn’t conduct a hazard evaluation for every sort of meals manufactured, processed, packed or held at their facility to establish and consider recognized or moderately foreseeable hazards to find out whether or not there are any hazards requiring a preventive management, as required. They haven’t performed a hazard evaluation that covers RTE noodles manufactured by their agency (i.e., steamed flour noodles, steamed egg noodles, and fried noodles).
a. The agency’s facility manufactures RTE steamed egg noodles, RTE steamed flour noodles, and RTE fried noodles, that are uncovered to the atmosphere after cooking and previous to packaging. Their staff hand-pack the meals, and the packaged meals doesn’t obtain a deadly remedy or in any other case embrace a management measure (similar to a formulation deadly to the pathogen) that will considerably reduce pathogens on the packaging step. A educated individual manufacturing/processing meals of their circumstances would establish contamination with environmental pathogens similar to Salmonella spp. or Listeria monocytogenes, as a recognized or moderately foreseeable hazard requiring a preventive management. Moreover, the agency doesn’t monitor sanitation or conduct environmental monitoring.
Sanitation controls embrace procedures, practices and processes to make sure that the power is maintained in a sanitary situation satisfactory to considerably reduce or stop hazards similar to environmental pathogens and organic hazards because of worker dealing with. As well as, environmental monitoring is required if contamination of a RTE meals with an environmental pathogen is a hazard requiring a preventive management. They’re additionally required to ascertain and implement an environmental monitoring written process.
The agency has a written sanitation process below the “Sanitation Preventive Controls” part of their Meals Security Plan for his or her non RTE merchandise. Nonetheless, this process states the aim is to “Clear meals allergen (egg merchandise) earlier than making new merchandise.” The listing of apparatus below “Location” doesn’t embrace tools and areas of their facility the place RTE steamed egg noodles, RTE steamed flour noodles and RTE fried noodles are additionally susceptible to contamination with pathogens because of worker dealing with.
As well as, the next observations have been made on Sept. 19, 2023 throughout manufacturing:
i. An worker was noticed utilizing their gloved fingers to pack RTE steamed flour noodles and RTE steamed egg noodles into plastic luggage. The worker momentarily stopped hand packing the RTE noodles and was noticed touching non-food contact surfaces (e.g., cardboard containers and doorknobs). The worker then returned to the station and resumed hand packing the RTE steamed flour noodles with out first washing or sanitizing their fingers or altering their gloves. As well as, the identical worker was noticed touching the within of the plastic luggage (food-contact floor) on the time they resumed packing the RTE steamed flour noodles.
ii. An worker was noticed utilizing their gloved fingers to pack RTE steamed egg noodles into plastic luggage. The identical worker was noticed dealing with cardboard after which returning handy pack the RTE noodles with out first washing or sanitizing their fingers or altering their gloves.
4. The agency’s written supply-chain program doesn’t present assurance {that a} hazard requiring a supply-chain-applied management has been considerably minimized or prevented, as required. Particularly, their hazard evaluation for his or her non-RTE meals merchandise appropriately recognized mycotoxins hazard for his or her wheat flour which is utilized in each product manufactured by their agency as a hazard requiring a preventive management. Their hazard evaluation signifies that this hazard is managed by their provider by acquiring a Certificates of Evaluation (COA) to substantiate. Nonetheless, the agency was not reviewing COAs.
Present Good Manufacturing Observe
1. The agency didn’t take cheap measures and precautions to make sure all individuals working in direct contact with meals, food-contact surfaces, and food-packaging supplies conform to hygienic practices whereas on obligation to the extent vital to guard towards allergen cross-contamination and towards contamination of meals, as required. Particularly,
a. On Sept. 19, 2023, an worker was leaning over a stainless-steel desk the place uncovered RTE steamed egg noodles have been left to chill after being steamed. The worker’s visibly dirty apron made contact with the uncovered RTE noodles.
b. On Sept. 19, 2023, an worker was utilizing visibly dirty towels to retrieve steamed RTE steamed egg noodles trays from the steamer. The dirty towels got here into contact with the RTE steamed egg noodles.
c. On Sept. 18 and 19, 2023, a number of staff have been noticed utilizing their whole naked forearms to govern dough sheets. These staff didn’t wash their forearms or don disposable arm sleeves previous to dealing with the dough sheets with their naked forearms.
d. On Sept. 19, 2023, RTE steamed egg noodles have been unfold out over a stainless-steel desk to chill. These RTE noodles have been noticed coming into contact with an adjoining stainless-steel desk visibly lined with obvious mud.
2. The agency didn’t present satisfactory area for such placement of apparatus as is critical for upkeep, sanitary operations and the manufacturing of secure meals, as required. Particularly, stainless-steel tables the place RTE noodles are positioned to chill of their steam room are positioned immediately towards the wall permitting RTE steamed noodles to come back into contact with the wall. Additional, a wall noticed coming into contact with the RTE noodles on the stainless steel desk was visibly unclean.
3. The agency didn’t take efficient measures to exclude pests from the manufacturing, processing, packing, and holding areas and to guard towards the contamination of meals on the premises by pests, as required. Particularly,
a. On Sept. 18, 2023, one useless obvious cockroach was noticed within the manufacturing room behind the inoperable “Dough Mixer (redacted by FDA)” and subsequent to a storage container containing corn starch being use for the manufacturing of fried wonton dough.
b. On Sept. 18, 2023, three useless obvious cockroaches have been noticed contained in the three-compartment sink beside the place noodles have been being fried. One useless obvious cockroach was additionally noticed below the three-compartment sink. On Sept. 22, 2023, three useless obvious cockroaches and one reside obvious cockroach have been noticed inside the identical three-compartment sink.
c. On Sept. 19, 2023, one useless obvious cockroach was noticed within the drain situated between the frying station and the cooling desk situated contained in the frying room the place fried noodles are manufactured.
4. The agency didn’t preserve buildings, fixtures, and different bodily amenities of their plant in a clear and sanitary situation and in restore satisfactory to forestall meals from turning into adulterated, as required by 21 CFR § 117.35(a). Particularly, flooring all through the manufacturing and packing rooms, together with areas the place RTE meals are processed/packed, have been cracked, pitted and chipped in the course of the FDA walk-through on Sept. 18, 2023.
The complete warning letter may be considered here.
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