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By Michael S. Heyl, Attorney at Law

Just imagine. Your life science company--hypothetically speaking--is now a successful and growthoriented 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.