Risky Business: New Compliance Challenges for FDA-Regulated Industry

The FDA's Enforcement Initiative has created new challenges for regulated businesses. The agency is devoting significantly more resources to conducting inspections, with an increased emphasis on global supply chain quality. Moreover, the FDA is responding more rapidly and more aggressively to inspectional findings, placing greater importance on timely responses. In the past, firms with compliance problems often had ample time to implement corrective actions before the agency took enforcement action. Now, failure to respond to inspectional findings within fifteen days could trigger a Warning Letter or other significant enforcement action.