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Ingredient Company Cited For Refusing An FDA Inspection

Plan for inspections with an “FDA Inspection” SOP

Ingredient Company Cited For Refusing An FDA Inspection

International ingredient company cited for refusing an FDA GMP inspection, a serious prohibited act. #WarningLetterWednesday

What are the repercussions of denying inspections?

🔷All products from the facility are deemed adulterated, and it is a prohibited act to introduce products that are misbranded into interstate commerce. This is a serious offense!

🔷This company is located out of the country, and all products from their facility have been placed on an import alert, which means they will be rejected from entering the US.

🔷This will likely make future GMP inspections more rigid.

FDA is authorized to conduct unannounced inspections of ingredient or product companies that hold and sell in the United States at any reasonable time. The FDA is not required to give advance notice. In my experience, the FDA commonly shows up without warning on Monday morning, and dietary supplement GMP inspections usually last 3-5 days. Although it’s not required FDA typically does schedule inspections for international companies.

Refusing entrance to a facility or an area of the facility is considered inspection refusal. An unknowing front desk staff member may inadvertently turn away the FDA. This is one reason I suggest having a “What to do when the FDA arrives” SOP ready. Steven Yeager and I talk about this here

A side note on glycerin which is a common dietary supplement ingredient. As noted in this warning letter, in the past, glycerin has been adulterated with diethylene glycol (DEG), which can lead to fatalities. I suggest testing glycerin for DEG at least once annually.

If you are interested in good bedtime reading, here is the FDA document “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” 

Read the full warning letter here

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

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