If a supplier fails an FDA USP audit are all their products blocked for import or just the one that failed?

Global SourcesUpdated on 2024/05/21

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Full Question If our supplier fails a Food and Drug Administration (FDA) audit for a USP product, will the FDA put restrictions on that specific product or ALL THEIR OTHER PRODUCTS AS WELL, blocking them from import?

Answer Reader later wrote back having found an answer to her question. Posting here for reference to other readers.

"If a manufacturer fails an Food and Drug Administration (FDA) audit, the FDA will only put restrictions on the product in question, not all their products."

BTW, for our reader's information, USP stands for U.S. Pharmacopeial, which sets the standards for the quality of medicines and food ingredients in USA.

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