Recalls of food, drugs and medical devices continue to make headlines as the Food and Drug Administration (FDA) works to implement the Food Safety Modernization Act (FSMA) and focus on compliance with current good manufacturing process (CGMP) requirements with all FDA-regulated products.
As part of this effort, in January 2013 the FDA proposed a rule that would require manufacturers of food to maintain a recall plan that would evaluate the severity and scope of the recall; notify the FDA, consumers and the public; and secure insurance coverage for potential losses and liabilities. Manufacturers with no experience writing recall plans or conducting recalls would be encouraged to consult with experienced regulatory personnel to be sure the plan is appropriate and complete. The rule also outlines the FDA’s authority to mandate recalls in certain cases for manufacturers of food, infant formula, medical devices and human biological products.
When manufacturers of food, drugs or medical devices identify a potential recall situation, they must determine the level and depth of the problem. Recalls are broken into three classes, the highest of which, known as a Class 1, is reserved for products in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. If a manufacturer identifies a potential Class 1 recall situation, the company is required to report it to the FDA within 24 hours.
If the FDA determines that a product carries a reasonable probability that it could be harmful to consumers, the agency may ask the manufacturer to recall the product voluntarily. If the company refuses, the agency now has authority to issue a cease distribution order requiring the company to “immediately” cease distributing the item and notify customers of a recall.
Having a solid recall plan in place that requires manufacturers to act quickly not only protects customers from potentially harmful products but also avoids or limits any damage to their business and reputation. It can also help the company avoid litigation and in some cases criminal charges.