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  • ab2346 replied to the topic Safety Recalls in the forum Introduction to Project Management 6 years, 2 months ago

    Part of the FDA requirements is that labels and markings have to be correctly placed on the device. They have to be visible and clear for the user. If they’re not, then they’re breaking FDA compliance and must order a recall. One article said: “In July 2014 alone there were 143 recalls due to labeling issues, 94 of which were food products. The labeling issues included improper claims, such as claiming to be organic, and missing or incorrect required information like instructions, ingredients, and expiration dates. FDA label requirements can be complicated. Registrar Corp can revise your food, drug, medical device or cosmetic label to comply with U.S. FDA regulations.” This makes it clear that the FDA is serious about correct labeling. The company should also be willing to recall the product in the first place because it will show its customers that it is serious about their safety.