In August, we reported that the FDA will begin in October inspecting the facilities of all U.S.-based tobacco product manufacturers subject to the FDA’s authority.Troutman Sanders has for years been assisting clients in a variety of industries with product liability audits. These audits can be an invaluable tool for the tobacco industry as it prepares for FDA inspections.
Product liability audits can consist of a review of the company’s documentation, including documentation relating to the company’s equipment, manufacturing and sales, correspondence with government agencies and policy manuals. The product liability audit may also include ways to avoid product liability claims, ways to protect against defect injuries, public relations, document control and insurance considerations.
While there is no means of completely removing a company’s liability for allegedly defective products, taking proactive steps to assess liability and propose alternatives through a product liability audit will help to minimize the overall liability of the company. Although senior management is often well-equipped to deal with the issues facing the business, the availability of outside counsel to provide independent legal analysis, to bring their considerable expertise to the table, and to provide a privileged analysis of relevant issues, underscores the benefits of a product liability audit.