Key Takeaways: GMP Enforcement
FDA is now putting more focus on international suppliers, and soon will have even more inspection resources
Companies need to re-examine their relationships with third party product and service suppliers
Companies must have a rigorous GMP audit program for their suppliers
More than ever, companies need to ensure that their 483 responses directly address all of FDA’s concerns and provide firm commitments to rigorous corrective action
The agency may use GMP inspections and Warning Letters to raise other compliance violations
FDA is closely scrutinizing the effectiveness of Quality Control Units
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