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.
Market of Choice LLC
Eugene, OR
A food firm in Oregon is on notice from the FDA for labeling and allergen violations which has resulted in a total of four recalls in the past five years.
In a June 1 warning letter, the FDA described a Dec. 22 and 29, 2020, Dec. 21, 2020, and Jan 4-5 and 14, 2021, inspection of Market Choice LLC in Eugene, Oregon.
The FDA’s inspection revealed that the firm was not in compliance with Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulations and resulted in the issuance of an FDA Form 483.
The firm’s significant violations regulation are as follows:
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
- The firm did not appropriately identify undeclared allergens as a hazard requiring a preventive control in their allergen-containing products. Their facility receives, stores, and uses allergens such as tree nuts, peanuts, milk, eggs, soy, and wheat in production. Their allergen hazard analysis, written in their document entitled “Preventive Control for Allergens – All Products,” dated Nov. 15, 2020, indicates that the allergen hazard was not significant because of low likelihood. As part of their hazard evaluation, the firm is required to evaluate known or reasonably foreseeable hazards to assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls. Because they use these allergens in their products, the likelihood of an allergen being present is not low. Moreover, allergens can cause serious adverse health consequences or death. Thus, the firm’s hazard analysis should have concluded that food allergens are a hazard requiring preventive controls.
Food allergen controls include procedures, practices, and processes to control food allergens, including those employed for labeling the finished food to ensure it is not misbranded under section 403(w) of the Act [21 USC 343(w)]. Preventive controls required under §117.135 are subject to preventive control management components (i.e., monitoring, corrective actions and corrections, and verification) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. The firm must also conduct a reanalysis of the food safety plan as a whole, or the applicable portion of the food safety plan whenever a significant change in the activities conducted at their facility creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard. The FDA notes that in 2020, after the firm’s corporate office modified the recipe for Sour Cherry Baked Brie by adding almonds, a tree nut which is one of the major food allergens (a significant change), they did not update electronic allergen declarations or otherwise inform their retail stores of the almond addition before they printed and applied labels to individual units. As a result, on Dec. 4, 2020, the firm initiated a Class I recall of the Sour Cherry Baked Brie because of undeclared almonds. Further, they have had a total of four Class I and two Class II recalls involving undeclared allergens in the past five years.
The FDA received the firm’s document entitled “New Product Label Verification Checklist” submitted with their Jan. 27, 2021, written response to the inspection. However, this procedure for new product development does not appear to address the root cause of the recall – failure to make electronic allergen labeling revisions after reformulations that add or change the allergens in a product. In addition, the FDA said, the procedure does not include monitoring, corrective action, or verification procedures to ensure control of the undeclared allergen hazard. Furthermore, they did not submit example completed records as evidence that the procedure is being implemented. Lastly, they did not submit a revised hazard analysis showing that the hazard of undeclared allergens requires a preventive control in their allergen-containing products. The firm’s Feb. 1, 2021, written response did not address the undeclared allergen hazard in their facility.
- The firm did not appropriately identify contamination with environmental pathogens, such as Listeria monocytogenes and Salmonella, as a hazard requiring a preventive control in their ready-to-eat (RTE) salads. Specifically, their document entitled “Food Safety Hazard Analysis Worksheet and HACCP Plan (redacted) for Fresh Salads,” dated July 20, 2020, indicated that biological pathogens are not significant at the peel/trim/cut and packaging steps. However, their RTE fresh salads are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure that would significantly minimize environmental pathogens. Listeria monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE salads, exposed to the environment. Thus, their hazard analysis should have concluded that environmental pathogens such as Listeria monocytogenes are a hazard requiring preventive controls (i.e., sanitation controls) and that the controls need to be verified by environmental monitoring, e.g., for Listeria monocytogenes or an appropriate indicator organism. Note that these controls and the environmental monitoring procedures must be written.
According to their document entitled “InSite Salmonella Result Record,” on (redacted), and (redacted), they obtained six Salmonella positive swab results in (redacted) in the (redacted) room, (redacted) room, and (redacted) area. These rooms are adjacent to the main production room where ready-to-eat products are exposed to the environment prior to packaging. They are required to establish and implement written corrective action procedures that must be taken to address the presence of an environmental pathogen or appropriate indicator organism detected through environmental monitoring conducted in accordance with 21 CFR 117.165(a)(3). The corrective action procedures must describe the steps to be taken to ensure, among other things, that appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur, and all affected food is evaluated for safety. The FDA notes that they did not take such corrective actions when they detected environmental pathogens on (redacted) and (redacted).
The FDA received their documents entitled “Listeria Monocytogenes Summary Control Plan” and “Salmonella Summary Control Plan” submitted with their Jan. 27, 2021, written response to the inspection. In the firm’s response, they indicated that they would complete the corrective actions for environmental monitoring positive results by March 1, and would begin implementing their new environmental monitoring procedures by March.
To date, the FDA has not received any updates documenting their progress.
Lastly, they did not submit a revised hazard analysis showing that the hazard of contamination with environmental pathogens requires a preventive control for their RTE products exposed to the environment prior to packaging. The firm’s Feb. 1 written response did not address this hazard in their facility.
The full warning letter can be viewed here.
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