Manufactring expiration dating policy

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Lack of an ongoing testing program to verify product stability after the shelf life has been determined appropriate.

Lack of follow-up studies at the labeled storage conditions or, if there are no storage conditions specified, at room temperature, for drug products for which the shelf life was determined by accelerated studies.Consumers must evaluate the quality of the product prior to its consumption to determine if the product shows signs of spoilage.Open dating is found on most foods including meat, poultry, egg and dairy products."Closed or coded dates" are a series of letters and/or numbers and typically appear on shelf-stable products such as cans and boxes of food.The purpose of this guide is to delineate those situations in which the Center is prepared to consider regulatory action.Lack of a labeled date indicating stability after reconstitution or lack of studies to support the appropriateness of that date.

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