As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. 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. The FDA frequently redacts parts of warning letters posted for public view.
Ding Tea Balboa
San Diego, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Dec. 9, 2021, warning letter the FDA described a Sept. 16-17, 2021, Foreign Supplier Verification Program (FSVP) inspection of Ding Tea Balboa in San Diego, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Thai Tea Powder imported from (redacted)
- (redacted) imported from (redacted), located in (redacted)
- Hazelnut Syrup imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
5,000 Years Foods Inc.
A food company in Illinois is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, specifically in regard to Listeria and pests.
In a Jan. 27 warning letter, the FDA described a June 14 through Aug. 3, 2021, inspection of 5,000 Years Foods Inc. kimchi operation in Chicago, IL.
The FDA’s inspection revealed that the firm was not in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation and resulted in the issuance of an FDA Form 483.
Some of the significant violations:
Hazard Analysis and Risk-Based Preventive Controls:
- The firm’s hazard analysis did not evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control for its ready-to-eat (RTE) kimchi products (e.g., sliced cabbage kimchi, cube cut radish kimchi, and white whole kimchi). The firm’s “Hazard List” consisted of a number of potential hazards but did not evaluate which ones actually require a preventive control.
- The firm did not evaluate environmental pathogens, such as Listeria monocytogenes, to determine whether they are a hazard requiring a preventive control. For example, the firm manufactures ready-to-eat sliced cabbage kimchi that 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). The firm’s “Hazard List” identified but did not otherwise evaluate contamination from the “food handling environment.”
FDA’s inspection included the collection of environmental swabs on June 15, 2021, during the production of ready-to-eat (RTE) kimchi, and confirmed five of 66 swabs positive for Listeria monocytogenes. Of the positive findings, three swabs were collected from areas adjacent to food-contact surfaces where RTE ingredients were being prepared, including:
- The topside of a large white cutting board used to hold baskets of cabbage for draining after brining and rinsing. During the inspection, cabbage was observed hanging off the side of the baskets and in direct contact with cutting boards.
- The 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.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
- The firm did not take effective measures to exclude pests from their manufacturing, processing, packing, and holding areas to protect against contamination of food.
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.
- The firm 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 workstation, and at any other time when the hands may have become soiled or contaminated.
Specifically, during the inspection:
- 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.
- 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. The firm 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.
- The firm 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.
- The firm 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:
- On June 14, 2021, a half head of cabbage was observed to fall out of a bin onto the floor of the facility. An employee 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.
- 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.
- 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, they indicated that the sponge is soaked in a (redacted) solution.
- The firm’s equipment and utensils were not designed, constructed, and used appropriately to avoid the adulteration of food with contaminants. Specifically, during the inspection the (redacted) blades and other food-contact mechanisms were observed to have been recently painted. The firm indicated that “(redacted)” 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, the firm’s officials stated that they would discontinue use of this paint and would research paints intended for safe use on food-contact surfaces.
The full warning letter can be viewed here.
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