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U.S. Department of Health and Human Services

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Why isn’t a drug taken off the market when a manufacturer gets a Warning Letter?

Warning Letters generally cause manufacturers to quickly and cooperatively correct problems. In some cases, this may mean that the product needs to be temporarily removed from the market or production must be stopped until the problem is resolved. In other cases, the problem may not require the manufacturer to stop its product from being sold. As with other product safety decisions, completely removing a product from the market, based on the problems justifying a Warning Letter, can also be dangerous to people who need the product. Warning Letters often help to solve product problems without having to remove necessary products from the market.

When necessary, for drug manufacturers who receive Warning Letters, FDA may withhold approval of a new drug from that manufacturer until identified manufacturing problems that may affect the new drug are corrected. In addition, for foreign drug manufacturers who receive Warning Letters, FDA may refuse to allow the manufacturer’s drug to be imported for sale in the United States until the problems that may affect the drug are corrected.

In cases when FDA finds that a manufacturer refuses to fix problems after receiving a Warning Letter, the agency can take additional measures to protect public health. For instance, FDA can quickly issue a press release or consumer alert to notify the public not to use the product. Additionally, FDA can take legal action to seize batches of a drug or to stop a company from further manufacturing and distributing the drug.

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