The FDA gained mandatory recall authority in 2011 when FDA’s Food Safety Modernization Act (FSMA) went into effect. If the agency determines that a food is adulterated or misbranded the FDA has the authority to order a recall for that food.
The guidance addresses important questions, a few are:
- Why is mandatory food recall authority important?
- What foods are subject to the FDA’s mandatory food recall authority?
- What is a responsible party under section 423 of the FD&C Act?
- What are the criteria for a mandatory recall?
- What process will FDA follow for a mandatory recall?
- When is a food considered adulterated under section 402 of the FD&C Act?
- When is a food considered misbranded under section 403(w) of the FD&C Act?
- Product analysis for microbial and chemical safety to ensure food is not adulterated
- Product full label review for compliance to avoid misbranding
- Product nutritional analysis and nutrition fact creation and review to avoid misbranding
- Product Food Safety Plan/HACCP creation and consultation for overall food safety and compliance
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