While on inspection, FDA reviews multiple investigation reports related to product dryer failures. These failures occur sporadically, but after investigation, your site has claimed that there is no risk to the product quality or safety. As a result, your company is still using the equipment to manufacture and release product to the market, even though you have not found the root cause for the failures to fix the problem. What is the most likely FDA response to this situation? (Select all that apply)

Question

While on inspection, FDA reviews multiple investigation reports related to product dryer failures.  These failures occur sporadically, but after investigation, your site has claimed that there is no risk to the product quality or safety.  As a result, your company is still using the equipment to manufacture and release product to the market, even though you have not found the root cause for the failures to fix the problem.  What is the most likely FDA response to this situation?  (Select all that apply)

Answer

FDA indicates that you must purchase new dryers

Answer

FDA indicates that it is not acceptable for you to continue to use the dryers

Answer

FDA indicates that you must find the root cause for the failures

Answer

FDA agrees that it is ok to use the dryers since there is no risk to the product quality or safety

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While on inspection, FDA reviews multiple investigation reports related to produ...

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