Monday, September 21, 2009

FDA Offers Warning Letter Close-Out Letter Program

According to the FDA's announcement, Warning Letter Close-Out Letter Program, the FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

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