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April 23, 2024

WARNING LETTER

Reference: CMS Case # 672206

Dear Mr. Zheng:

The United States Food and Drug Administration (FDA) inspected your manufacturing facility located at 1140 W Louisiana Avenue, Denver, Colorado from September 18, 2023 to October 23, 2023. The inspection inspection inspection significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we have determined that your ready-to-eat (RTE) egg, flour, and fried noodle products and not-ready-to-eat (NRTE) wonton, egg roll, and dumpling wrapper products manufactured in your facility 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 are prepared, packed or held under insanitary conditions whereby they may be may may be contaminated with filth or whereby they may be may be rendered injurious to health. End of
Translation In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. Additionally, the inspection found your firm failed to register as required in section 415 of the Act [21 U.S.C. § 350d], and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR § 1.225 -1.245]. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. You may find the Act and FDA’s regulations through links on FDA's website at www.fda.gov.

At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided a response to the inspection on October 31, 2023, describing corrective actions taken by your firm. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response below.

Your significant violations are as follows:

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. You 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 your non-RTE egg roll wrappers, wonton wrappers, dumpling wrappers, fresh flour noodles, and fresh egg noodles, as required by 21 CFR 117.130(a)(1). Specifically, your facility’s written hazard analysis for your 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. You manufacture 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 your 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 (see 21 CFR § 117.135(c)(2)).

We note that you do not have adequate controls in place for undeclared allergens as evidenced by your distribution of unlabeled bags of RTE steamed flour noodles (contain wheat), non-RTE flour noodles (contains wheat), and non-RTE egg noodles (contain wheat and egg) to consumers (retail) and restaurants (wholesale) who purchase the unlabeled noodles onsite at your firm.

Your October 31, 2023, response states all packaged ingredient labeling will be corrected and replaced. You also indicate “packaged noodles will be placed in assigned labeled areas in walk-in cooler.” Your response did not indicate whether you have conducted a hazard analysis for your RTE products. We cannot evaluate the adequacy of your corrective actions because you have not provided supporting documentation to demonstrate a preventive control, including applicable preventive control management components, is in place to adequately control the hazard of undeclared allergens.

You were notified by FDA via phone on November 16, 2023, that your unlabeled products distributed to walk-in customers (retail and wholesale) pose a risk to public health because the products contain undeclared allergens (egg and/or wheat).

2. You did not implement your preventive control procedures to provide assurances that the hazard of allergen cross-contact will be significantly minimized or prevented as required by 21 CFR 117.135(a)(1).

You manufacture your 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. Your 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 your Food Safety Plan, it states cleaning is to occur “(b)(4) after egg noodles are made.” However, you did not implement your procedure that states “Manager on shift will come by and checked [sic] everything is cleaned properly and signed [sic] sanitation records.” You were unable to provide any monitoring records to demonstrate your preventive control for the hazard of allergen cross-contact is consistently performed.

You process 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. We note that you do not have adequate controls in place for allergen cross-contact as evidenced by the following observations made on September 22, 2023, after cleaning of shared pieces of equipment:
a. Your “Dough Mixer (b)(4)” was observed with apparent food product residue on the food-contact surfaces of the mixer blades, interior wall surfaces, and bolts.
b. Your “Dough Folder (b)(4)” 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. Your “Dough Folder (b)(4)” 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. Your noodle cutting machine was observed with apparent egg dough residue on the food-contact surfaces.

In addition, you do not have written corrective action procedures, as required by 21 CFR § 117.150(a)(1), and written verification procedures, as required by 21 CFR § 117.165(b).

Subsequently, on September 22, 2023, you processed dough for dumpling wrappers which do not contain egg on this same equipment.

Your October 31, 2023, response states all shared equipment will be disinfected with a (b)(4) solution, re-wiped with a clean towel soaked in hot water, then sanitized after egg noodles are made. You indicate that after cleaning “observations will be made and corrected if necessary.” It is unclear from your response what “observations will be made” is referring to. We note the cleaning process described in your response for shared equipment does not appear to differ significantly from the cleaning procedure observed during our inspection. It is unclear if your cleaning procedure would be adequate if properly implemented by your employees. Your response also included information indicating that shared equipment will be properly cleaned/sanitized before every use. You also indicate records for “cleaning and monitoring” will be kept and sanitation training will be done (b)(4). It is unclear from your response what you plan to monitor to provide assurance that your preventive control for the hazard of allergen cross-contact is consistently performed.

We cannot evaluate the adequacy of your corrective actions because you have not provided supporting documentation to demonstrate a preventive control, including applicable preventive control management components, is in place to adequately control the hazard of allergen cross-contact.

3. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a). You have not conducted a hazard analysis that covers RTE noodles manufactured by your firm (i.e., steamed flour noodles, steamed egg noodles, and fried noodles).
a. Your 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. Your 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 your 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, your 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 (see 21 CFR § 117.135(c)(3)). In addition, environmental monitoring is required if contamination of a RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)). Note that you are also required to establish and implement an environmental monitoring written procedure (see 21 CFR § 117.165(b)(3)).

You have a written sanitation procedure under the “Sanitation Preventive Controls” section of your Food Safety Plan for your 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 your 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 September 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.

Your October 31, 2023, response states the cooling table with RTE fried noodles will be left in the kitchen with the doors closed. You also indicate cooling tables will be “completely sanitized before every use.” However, your response did not indicate whether you have conducted a hazard analysis for your RTE noodles and identified a preventive control for the hazard of contamination with environmental pathogens.

Additionally, your October 31, 2023, response states, “extra measures and precautions will be taken for personnel practices” and practices that are not adequate will be addressed on-sight. Measures described in your response include “handwashing technique (also up to the forearm), removing and wearing new disposable gloves and arm sleeves upon re-entry, and making sure employee’s food is not in production areas.” You also indicate employees will be retrained on food safety and hygiene, which will be implemented (b)(4) and documented. We will verify implementation of these corrective actions during our next inspection of your facility.

Your response also included information on how the RTE steamed flour and RTE steamed egg noodles would be processed. However, the corrective action provided relates to control of allergen cross-contact and not contamination with environmental pathogens.

4. Your 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 by 21 CFR § 117.410(c). Specifically, your hazard analysis for your non-RTE food products appropriately identified mycotoxins hazard for your wheat flour which is used in every product manufactured by your firm as a hazard requiring a preventive control. Your hazard analysis indicates that this hazard is controlled by your supplier by obtaining a Certificate of Analysis (COA) to confirm. However, your firm was not reviewing COAs.

Your October 31, 2023, response indicated “all suppliers will be notified to provide COA to confirm any micro toxins and controlled mycotoxins.” In addition, “BOL, and (b)(4) audits will also be requested for approval and activity verification.” We note you are required to approve suppliers in accordance with the requirements of 21 CFR § 117.410(d), and document that approval, before receiving raw materials and other ingredients from those suppliers (see 21 CFR § 117.420(a)). However, it is unclear from your response if you have approved your suppliers.

Current Good Manufacturing Practice (21 CFR Part 117 Subpart B):

1. You 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 by 21 CFR § 117.10(b). Specifically,
a. On September 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 September 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 September 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 September 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. You 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 by 21 CFR § 117.20(b)(1). Specifically, stainless steel tables where RTE noodles are placed to cool in your 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. You 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 by 21 CFR § 117.35(c). Specifically,

a. On September 18, 2023, one (1) dead apparent cockroach was observed in the production room behind the inoperable “Dough Mixer (b)(4)” and next to a storage container containing corn starch being use for the manufacturing of fried wonton dough.

b. On September 18, 2023, three (3) dead apparent cockroaches were observed inside the three-compartment sink beside where noodles were being fried. One (1) dead apparent cockroach was also observed under the three-compartment sink. On September 22, 2023, three (3) dead apparent cockroaches and one (1) live apparent cockroach were observed inside the same three-compartment sink.

c. On September 19, 2023, one (1) 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.

Your October 31, 2023, response stated “the manager or owner will conduct routine inspections of the entire facility, paying special attention to entry points, storage areas, production zones, and kitchen as well as utilize pest monitoring devices, such as traps and sensors, to detect pests early.” You also indicated potential entry points will be sealed which includes gaps “in/between the doors and walls.” We will verify implementation of these corrective actions during our next inspection of your facility.

4. You did not maintain buildings, fixtures, and other physical facilities of your 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 September 18, 2023.

Food Facility Registration:

The FDA has determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d] and our implementing regulation at 21 CFR Part 1, Subpart H (21 CFR § 1.225 -1.245). The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that as of the date of this letter, your facility is not currently registered.

As a responsible official of a facility that manufactures, processes, packs, or holds food for consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately.

Registration may be submitted electronically at http://www.fda.gov/furls. We strongly encourage the use of electronic format as it is more efficient and provides for immediate submission of the registration information and immediate issuance of the registration number.

Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form can be downloaded at: http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm073728.htm or can be obtained by calling the FDA Industry Systems Help Desk at 1(800) 216-7331 or (240) 247-8804, or by writing to the agency at the following address:

U.S. Food and Drug Administration, HFS-681
Food Facility Registration (HFS-681)
5001 Campus Drive
College Park, Maryland 20740

When completed, the form may be faxed to (301) 436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number via email to the facility address provided.

The violations cited in this letter are not intended to be an all-inclusive list of violations 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 or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to do so may result in legal action by the FDA without further notice, including without limitation, seizure and injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

In addition to the violations described above, we offer the following comments:

• We note that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility, and the individual's assigned duties, as required by 21 CFR 117.4(b)(2). You are required to establish and maintain documentation of this training for each individual, as provided by 21 CFR 117.4(d).

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov or at 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado. You may reach Ms. Jolly at carrie.jolly@fda.hhs.gov or (303) 236-9656.

Sincerely,
/S/

E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4