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FDA warning letters

FDA warning letters by company, newest first: who received one, the subject and the issuing office, each linked to FDA's own posting. Looking for one manufacturer? Look up its whole FDA record by name, site or FEI number.

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What a warning letter is

A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.

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