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World of Compliance Module

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If significant deviations are found, the district compliance branch makes a recommendation of follow-up action. OC's case management team reviews the inspection report findings and recommendations, determines the appropriate regulatory action and then drafts a decision memo. The Agency can then choose to warn the manufacturer by way of a warning letter, untitled letter or an injunction to cease drug manufacturing or distribution. Firms also submit corrective responses after receiving a warning letter or other regulatory action, and the OC reviews these responses to determine how adequately they address FDA concerns and whether or not additional inspections or actions are warranted to bring the firm into compliance with its regulatory responsibilities to protect the public health.

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