Are YOU Ready for an FDA Inspection? What Emerging Companies Need to Do to Prepare

FDA inspections are a fact of life for a wide range of organizations.  According to the budget request for fiscal year 2011, the FDA plans to hire more than 170 new inspectors in the field operations of the Office of Regulatory Affairs across the food and life science industries.  These additional inspectors are expected to conduct approximately 1,900 domestic food safety inspections and more than 600 risk-based inspections of foreign and domestic drug, device, radiological health, and biologic manufacturers, as well as bioresearch monitoring facilities.  An increased number of inspectors and inspections means that your facilities have a much greater chance of being inspected this year than in past years. There are serious financial consequences of a failed inspection.  Already this year, the agency has issued over 100 warning letters across all FDA-regulated industries.  The costs associated with receiving a warning letter can far outweigh the costs of preventing one.  For example, several of the warning letters require follow-up inspections, which can hit companies with a reinspection user fee, a relatively new initiative that requires organizations to pay the full costs of reinspections and associated follow-up work (averaging around $20,000) due to their failure to meet Good Manufacturing Practices (GMPs) or other important FDA requirements.  In addition to the monetary implications, failed inspections can really deal a blow to a brand’s reputation and credibility.

The 2011 budget plan essentially boils down to more inspectors, more inspections, and greater ramifications.  Regardless of the size of your company, no one likes paying for mistakes that could have been avoided to begin with.  Unfortunately, however, smaller companies will feel the impact of these costs to a greater degree than larger companies.  Because they simply cannot afford the consequences of a failed inspection, it is therefore essential that smaller companies prepare themselves in advance of an inevitable inspection.

Faced with the same rigorous quality and regulatory requirements as multibillion-dollar organizations, while not having the same expansive resources and budget, emerging companies need to eliminate error-prone legacy systems and implement out-of-the-box versions of top-notch quality and regulatory management software that can help companies achieve compliance.  Advanced systems that can track, trend, and report on critical business processes, such as deviations, audits, change control, complaint tracking, and supplier quality management, will help inspections go smoothly and assist organizations in preparing in advance to avoid the associated costs of a failed inspection.

By hiring more inspectors, the FDA is sending a strong warning message to all regulated industries.  Your organization can better prepare for the inevitable audit now by automating and streamlining quality and regulatory processes with best-in-class software technology that will put you ahead of the curve and facilitate the inspection process to increase your chances of surviving the scrutiny of the FDA.  Want to know what to do when the FDA comes knocking?  Contact us.

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