Market of Choice receives FDA warning letter after four recalls in the past 5 years

market of choice receives fda warning letter after four recalls in the past 5 years

Sumary of Market of Choice receives FDA warning letter after four recalls in the past 5 years:

  • As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction..
  • 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..
  • The FDA 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 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,”.
  • 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..
  • Thus, the firm hazard analysis should have concluded that food allergens are a hazard requiring preventive controls….

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