The U.S. Food and Drug Administration on March 3, 2022, finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures the include training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk.
A voluntary recall is an action taken by a company to correct a violative product or remove it from the market. A recalling company may act on its own initiative or the FDA may inform the company that a distributed product violates the law and recommend the company recall the product. The FDA has the authority to require recalls … [Read more]