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  • Sk90 replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago

    FDA and manufacturer monitors the products in the market whenever the manufacturer founds any product defective or potential harmful they would recall it or sometime FDA recalled the product after customer complaints. There can be number of reasons like health hazard,poorly packed or labeled. Recall effects the business badly ,it often tarnishes the brand behind the product due to the lack of faith in the products they produce, causing sales to decrease. It can be avoided by using highly specialized skills in quality control, automated manufacturing, validation, and verification. From the initiation phase make sure that the product is defect free. All segments of the supply chain must work tightly together to avoid product recalls Damage occurred during transportation of product also causes recall that means the product should be delivered unspoiled to the end customer. The product should be closely monitored during design and production phase and even after production stage to identify the defect and deal with them. Any changes regarding. design,engineering,manufacturing ,cost, performance should not effect safety of product.