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If you’ve ever received a Form 483, you know the FDA gives you one chance to make things right: a 15-day window in which to submit to the agency a written response that addresses the observations in the 483 and outlines your plans for improvement. Can you fix your corrective and preventive action (CAPA) problems in 15 days? It’s not likely, but you can show the agency you understand the issues and are committed to resolving them.