FDA restrictions after supplier fails an FDA audit

If our supplier fails an FDA audit for a USP product, would the FDA put restrictions on that specific product or ALL THEIR OTHER PRODUCTS AS WELL, blocking them from export?


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

“If a manufacturer fails an FDA audit, the FDA would only put restrictions on the product in question, not all their products.”

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

Wishing you successful China sourcing!

Question answered by Mike Bellamy, host of “Ask the Experts” at the China Sourcing Information Center.

Mike Bellamy is an Advisory Board Member & Featured Blogger at the not-for-profit China Sourcing Information Center (www.ChinaSourcingInfo.org). He is also the author of, “The Essential Reference Guide to China Sourcing” (chinasourcinginfo.org/book) and founder of PassageMaker Sourcing Solutions (www.PSSchina.com )

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