以消费者为中心的召回现代化举措.pdf

1、Recall Modernization Initiatives with the Consumer in MindSponsored by:InstantRecallLearning objectives:Gain a greater appreciation of why recall modernization is so critical from both a consumer perspective and industry perspective Understand the current state of regulatory recall programs both for

2、 FDA and USDA Understand the various industry-and association-led initiatives underway to help modernize the recall process and how you can helpFDA Recall Classifications Class I recall:a situation in which there is a reasonable probability that the use of or exposure to a violative product will cau

3、se serious adverse health consequences or death.Class II recall:a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.Class III recall:a situatio

4、n in which use of or exposure to a violative product is not likely to cause adverse health consequences.Market withdrawal:occurs when a product has a minor violation that would not be subject to FDA legal action.The firm removes the product from the market or corrects the violation.For example,a pro

5、duct removed from the market due to tampering,without evidence of manufacturing or distribution problems,would be a market withdrawal.USDA Recall Classifications Class I-A Class I recall involves a health hazard situation where there is a reasonable probability that use of the product will cause ser

6、ious,adverse health consequences or death.Class II-A Class II recall involves a health hazard situation where there is a remote probability of adverse health consequences from use of the product.Class III-A Class III recall involves a situation where use of the product will not cause adverse health