- Delivery Method:
- Via Email
- Food & Beverages
Recipient NameSang Hong
- 5,000 Years Foods, Inc.
3465 N. Kimball Ave
Chicago, IL 60618
- Issuing Office:
- Office of Human and Animal Food Operations, East Division VI
FY22-HAFE6-03 CMS 617797
January 27, 2022
Dear Mr. Hong:
The U.S. Food and Drug Administration (FDA or we) inspected your kimchi operation located at 3465 N. Kimball Ave, Chicago, IL 60618 from June 14, 2021 through August 3, 2021. FDA conducted this inspection as a follow up to the Regulatory Meeting held with your firm on February 21, 2019.
During the inspection, FDA investigators found serious violations, described below, of the 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). At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the ready-to-eat kimchi 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 United States Codes (U.S.C.) § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the requirements under Section 418 of the Act [21 U.S.C. § 350h] is a prohibited act under section 301(uu) of the Act [21 U.S.C. § 331(vv)]. You can find the Act and FDA’s regulations through internet links in FDA's home page at http://www.fda.gov.
We received your written responses dated July 3, 2021, and August 17, 2021, which included a summary of corrective actions by your facility. After reviewing the inspectional findings and your response to the observations listed in the FDA Form 483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. Your hazard analysis did not evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control for your ready-to-eat kimchi products (e.g., sliced cabbage kimchi, cube cut radish kimchi, and white whole kimchi), as required by 21 CFR 117.130(a). Your “Hazard List” consisted of a number of potential hazards but did not evaluate which ones actually require a preventive control. Specifically:
a. You did not evaluate environmental pathogens, such as Listeria monocytogenes, to determine whether they are a hazard requiring a preventive control, to comply with 21 CFR 117.130(c)(1)(ii). For example, you manufacture ready-to-eat sliced cabbage kimchi which is exposed to the environment at the steps of cabbage halving, brining, rinsing, draining, chopping, mixing with sauce, and packaging. The kimchi does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Thus, environmental pathogens are a hazard likely to occur in the absence of preventive controls (i.e., sanitation controls). Your “Hazard List” identified but did not otherwise evaluate contamination from the “food handling environment.”
We note that at the start of the inspection, your written procedures for sanitation of food-contact surfaces consisted of a generic “Cleaning and Disinfection” document downloaded from the internet, which indicated general tips for completing and checking sanitation tasks. The document was not specific to your facility or food. In addition, your monitoring record was a general-facility (b)(4) “Cleaning Record” which did not specify what was being cleaned or monitored and which was not subject to record review. Further, deficiencies in your sanitation monitoring are evidenced by FDA investigators’ observations on June 14-15, 2021, that the (b)(4) that was cleaned, sanitized, and deemed ready for production of ready-to-eat kimchi had apparent food residue on the blades and behind the feed mechanism used to push the (b)(4) through the (b)(4) blades.
During the closeout meeting at the end of the inspection, you provided an updated blank sanitation monitoring record (“Environm[en]tal Cleaning & Sanitizing Log”) with a statement at the top on how to clean and sanitize specific pieces of food-contact equipment such as the (b)(4), cutting boards, preparing tables, utensils, and kimchi mixer. The form did not cover your tanks for cabbage brining and mixing. The form instructed to clean with soap and water but did not describe the type and concentration of soap or the tools and technique for cleaning. The form instructed to sanitize the equipment “using a mixture of (b)(4) of (b)(4) to (b)(4)” but did not actually describe how to sanitize the equipment with the solution.
FDA’s current inspection included the collection of environmental swabs on June 15, 2021, during the production of ready-to-eat kimchi, and confirmed five (5) of sixty-six (66) swabs positive for Listeria monocytogenes. Of the positive findings, three (3) swabs were collected from areas adjacent to food-contact surfaces where RTE ingredients were being prepared, including:
• Topside of a large white cutting board used to hold baskets of cabbage for draining after brining and rinsing. During our inspection, cabbage was observed hanging off the side of the baskets and in direct contact with cutting boards.
• Underside of a white cutting board was used to hold draining baskets of cabbage.
• Side of wet and difficult to clean wooden crate used to hold cutting boards that were holding the draining baskets of cabbage.
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the environmental samples collected at your facility represent one (1) unique strain. We advised you of the importance of these WGS results via a conference call on September 10, 2021.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
Note that environmental monitoring is required when contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). Environmental monitoring is used to verify that sanitation preventive controls are designed and functioning to reduce the hazard of environmental pathogens such as Listeria monocytogenes contaminating your finished product.
You sent a response to the FDA Form 483 on August 17, 2021, and a response to the Listeria monocytogenes positive samples on July 3, 2021, including finished product testing results negative for Listeria monocytogenes and a finished product pH result of (b)(4). In addition, after receiving the FDA results you conducted a recall of your kimchi products that were manufactured when FDA collected the samples. Your responses also included an updated hazard analysis but it did not consider pathogens at processing steps subsequent to vegetable receiving and storage (e.g., cabbage halving, brining, rinsing, draining, chopping, mixing with sauce, and packaging steps). For written procedures for sanitation of food contact surfaces and associated monitoring, you submitted the same “Environm[en]tal Cleaning & Sanitizing Log” that you provided at the closeout meeting. For environmental monitoring, you submitted negative results from sampling and testing (mostly around the locations identified as positive by FDA). You also submitted a written procedure for environmental monitoring requiring (b)(4) swab samples on product-contact areas every (b)(4). However, the procedure did not meet requirements in 21 CFR 117.165(b)(3) for identifying the test microorganism, locations and timing for sampling, tests conducted, and laboratory conducting the testing. In addition, the corrective action plan in the procedure (“Sanitizing All areas, Keeping clean as much as possible”) did not adequately ensure that appropriate action is taken to identify and correct a problem that has occurred with implementation of a preventive control, as required by 21 CFR 117.150(a)(2)(i). Further, the corrective plan did not, as required by 21 CFR 117.150(a)(2)(ii)(iv). contain procedures to ensure the following:
• Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur;
• All affected food is evaluated for safety; and
• All food is prevented from entering into commerce, if you cannot ensure that the affected food is not adulterated.
In addition, your responses did not include a written recall plan, as required by 21 CFR 117.139(a).
b. You did not evaluate allergen cross-contact to determine whether it is a hazard requiring a preventive control. Your “Hazard List” identified but did not otherwise evaluate “allergenic cross-contamination.” Your facility manufactures multiple products with different allergen profiles on the same day and on shared equipment, which can result in allergen cross-contact without appropriate controls. For example, your sliced cabbage kimchi and your cube cut radish kimchi contain anchovy extract (in fish sauce) and shrimp allergens but your white whole kimchi does not contain any allergens. All kimchi products share common mixers and packaging tables. Therefore, you are required to identify and implement allergen preventive controls to provide assurances that the hazard of allergen cross-contact is significantly minimized or prevented, to comply with 21 CFR 117.135(a)(1) and (c)(2)(i). Your updated hazard analysis did not consider the hazard of allergen cross-contact and did not include any preventive controls to address the hazard.
c. You did not evaluate undeclared allergens due to an incorrect label to determine whether it is a hazard requiring a preventive control. Your “Hazard List” identified but did not otherwise evaluate “allergens and consumer informing.” Your facility manufactures sliced cabbage kimchi and cube cut radish kimchi which contain anchovy and shrimp allergens. Therefore, you are required to identify and implement allergen preventive controls to provide assurances that the hazard of undeclared allergens is significantly minimized or prevented, to comply with 21 CFR 117.135(a)(1) and (c)(2)(ii).
Your response to the FDA Form 483 included an updated hazard analysis that did not consider undeclared allergens. Although your response included a procedure for undeclared allergens, it did not specify anchovy as the type of fish allergen contained in the fish sauce. In addition, the monitoring procedure is unclear regarding the frequency with which labels are monitored during production of your products. Also, the corrective action plan (“Hold shipment if no signed allergen acknowled[g]ement letter available; Segregate/label packing”) did not address actions to be taken if an incorrect label is applied. Further, you submitted a Label Inspection Log in your response; however the log was blank, so implementation could not be evaluated.
d. You did not evaluate bacterial pathogens in your ingredients to determine whether they are a hazard requiring a preventive control (i.e., a supply-chain control) in your ingredients. Your “Hazard List” identified but did not otherwise evaluate food that “maybe hazardous due to insufficient or lack of controls in place by the supplier.” Your facility manufactures kimchi with cabbage, garlic, and green onion (e.g., sliced cabbage kimchi) and with radish (e.g., cube cut radish kimchi and white whole kimchi). These ingredients have been associated with pathogens such as Salmonella, pathogenic E. coli, and Listeria monocytogenes. Your facility also manufactures kimchi with red pepper powder (e.g., sliced cabbage kimchi and cube cut radish kimchi) which has been associated with pathogens such as Salmonella. You have not established a preventive control within your facility for a lethal treatment or formulation control for these pathogens. Therefore, you are required to establish and implement a supply chain program, covering pathogens in ingredients used to make ready-to-eat kimchi, to comply with 21 CFR 117.405(a)(1).
Your response to the FDA Form 483 included a supply-chain program. It required pathogens to be controlled via the supply-chain, and it stated that “Growers' information and documents regarding vegetables from vendors” will be checked. However, because the hazard is identified as “Vegetable Pathogen,” it was unclear whether the program covered the red pepper powder. In addition, the program did not specify the specific supplier information that will be reviewed regarding pathogens at each receipt, such as onsite audit results. Note that when a hazard in an ingredient will be controlled by a supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death, the appropriate supplier verification activity is an onsite audit, and the audit must be conducted before using the ingredient from the supplier and at least annually thereafter (unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled) as provided by 21 CFR 117.430(b).
Your response also included a procedure that requires “(b)(4)” or in an unspecified (b)(4) solution. The critical limits were “(b)(4).” However, you did not submit validation information to demonstrate that these limits would appropriately destroy pathogens. In addition, you did not submit implementation records.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not take effective measures to exclude pests from your manufacturing, processing, packing, and holding areas to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, the front door of the facility was observed left open throughout the inspection. On June 14-15, 2021, approximately five apparent flies were observed in the ready-to-eat kimchi production room, including on ready-to-eat cut cabbage prior to mixing and on ready-to-eat white whole kimchi prior to packaging.
At the closeout meeting, you promised to keep the front door closed in the future. Your response included a repair of the door to prevent pest entry. We will evaluate implementation during the next inspection.
2. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food wash their hands thoroughly (and sanitize if necessary, to protect against contamination with undesirable microorganisms) before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3). Specifically, during the inspection:
a. A gloved employee was observed exiting the facility, touching the outer door of the facility, touching the walls and doors of the refrigeration units, and then touching ready-to-eat cut cabbage without washing and sanitizing hands or changing gloves.
b. Gloved employees were observed using hoses, moving bins of mixed product, and carrying boxes of glass bottles during production. These employees then used their gloved hands to package the kimchi into jars, coming in direct contact with ready-to-eat product. You indicated that typically gloves are rinsed with water between production activities, but hands and gloves are not washed with soap or sanitized between production activities.
c. You indicated that the same pair of gloves are used throughout the day and are only changed daily or when ripped. For breaks, employees remove their gloves and place them on top of tables in the production room. When returning from breaks, hands are washed and the same pair of gloves is donned. However, the gloves are not washed with soap or sanitized before operations resume.
At the closeout meeting, you stated that employees have been retrained to clean and sanitize gloves between activities and after breaks. We will evaluate implementation during the next inspection. However, at the closeout meeting you did not address hand/glove hygiene upon touching an insanitary object or hand hygiene between activities. Your response did not address hand/glove hygiene.
3. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for the contamination of food, as required by 21 CFR 117.80(c)(2). Specifically:
a. On June 14, 2021, a half head of cabbage was observed to fall out of a bin onto the floor of the facility. You grabbed the cabbage with bare unwashed hands and handed it to a gloved employee. The employee rinsed the cabbage with water and placed it back into the bin for production of ready-to-eat kimchi. At the closeout meeting, you stated that employees have been instructed to throw away any food that touches the floor. We will evaluate implementation during the next inspection. Your response did not address the practice.
b. On June 14-15, 2021, hoses were observed laying on the floor in standing water. These hoses were then used to fill cabbage rinse tanks and were submerged in water. Your response included a photograph of a hose reel to prevent floor contact. We will evaluate implementation during the next inspection.
c. During the inspection, employees were observed using a sponge to wipe off the threads of jars of filled kimchi during packaging and before capping. The sponge came in contact with ready-to-eat product. On breaks and between production days, you indicated that the sponge is soaked in a (b)(4) solution. At the closeout meeting, you stated that the sponge will be stored in a (b)(4) solution at all times during manufacturing; however, you did not explain how contamination of the kimchi with (b)(4) will be prevented. Your response did not address this issue.
4. Your equipment and utensils were not designed, constructed, and used appropriately to avoid the adulteration of food with contaminants, as required by 21 CFR 117.40(a)(2). Specifically, during the inspection the (b)(4) blades and other food-contact mechanisms were observed to have been recently painted. You indicated that "(b)(4)" was used to cover up rusted areas on the equipment. This spray paint is not labeled for use on food-contact surfaces. At the closeout meeting, you stated that you would discontinue use of this paint and would research paints intended for safe use on food-contact surfaces. Your response included a photograph of food-grade spray paint and a piece of equipment recently painted with it. We will evaluate the adequacy of your corrective actions as well as implementation during the next inspection.
The violations cited in this letter are not intended to be an all-inclusive list of 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 or 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 administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comment regarding your sanitization of food-contact surfaces:
Your “Environm[en]tal [sic] Cleaning & Sanitizing Log” provided at the closeout meeting and in your response directs employees to mix (b)(4) with (b)(4). The solution is allowed to dry on the equipment. The form does not require a post-sanitization rinse step. You should ensure that your sanitizer solution does not exceed the maximum concentration for indirect food additives (see, e.g., 21 CFR 178.1010(c)(1)).
Please notify FDA in writing, within 15 working day of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as 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 Lauren Crivellone, Compliance Officer, HAFE6. If you have questions regarding this letter, please contact the Compliance Officer at (312) 596-4157 or via e-mail at: Lauren.Crivellone@fda.hhs.gov.
District Director, Chicago District Office
Program Division Director,
Office of Human and Animal Food Operations,
East Division VI