USA -FDA Warning Letter – 5,000 Years Foods, Inc.

FDA

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.External Link Disclaimer

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.

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