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Noncompliance to FDA Quality Standards: What's the Risk to Executives?

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White Paper 1 Noncompliance to FDA Quality Standards: What's the Risk to Executives Just imagine. Your life science company--hypothetically speaking--is now a successful and growth-oriented organization. Thus far, you've kept governmental regulations in check, quality is steadily improving, and you've even managed to lower the cost of production. Then one day when operations seem calm, smooth- -even simple--the U.S. Food and Drug Administration (FDA) shows up for an unannounced inspection of your facility. Your confidence is still high. Everything seems to be in order. The Bombshell After what seems to be a successful inspection, the FDA investigator leaves you with a Form FDA 483 list of inspectional observations at the close out meeting. Not only does the 483 include eight inspectional observations identifying deficiencies in the company's quality system, but one deficiency reigns supreme: "Management has not ensured that the quality system requirements are effectively established and maintained." How much could this cost upper management? How much could it cost your company? It could be hundreds-of- thousands. It could be millions. Heavy Responsibilities in High Places Life science companies rely on the expertise of dozens or even hundreds of employees. These employees provide the expertise that is essential to the health of an organization. However, the responsibility for their actions and for the systems they employ lies directly on the shoulders of upper management who can suffer both personally and financially the repercussions of decisions, actions or processes that do not conform to a company's quality policy or to regulatory requirements enforced by the FDA. In other words, upper management are "the few" and their responsibilities are "the great". This realization is humbling especially when the following facts are taken into consideration: 1) Under the Federal Food, Drug, and Cosmetic Act (FDC Act), the FDA is granted with broad inspectional authority. Under this authority, an FDA investigator can use his or her own judgment to determine whether or not upper management has control over the company's respective quality system; 2) In the FDA enforcement realm, the 483 is just the beginning. The FDA has the authority to issue warning letters to officially put a company "on notice" of violative behavior, and to seek administrative, civil, or even criminal actions against a company if warranted. 3) Moreover, the FDA can tie these actions directly to company management, and even seek personal liability against those in upper management.

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