Begin FDA Inspection Readiness Early Experts Say

Inspection readiness is more than a quick practice session before the FDA investigator arrives; preparation should begin long before an inspection is even announced, say regulatory experts who advise establishing standard operating procedures that will maintain a constant and thorough state of readiness.

Such procedures could include everything from creating a site overview slide deck covering key products, operations and people, to regular evaluations of the company’s weaknesses or potential areas of concern and ensuing corrective action.

John Taylor, president and principal of compliance and regulatory affairs at Greenleaf Health, says facilities’ SOPs for inspection management should contain clearly defined roles and responsibilities for staff before, during and after an inspection. And knowing these SOPs must be second nature given the stressful atmosphere of FDA inspections.

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