FDA Updates Guidance on Delay, Denial of Drug and Device Facility Inspections
The FDA recently released an updated guidance document on circumstances that it would consider to be delaying, denying, limiting inspection or refusing inspections of foreign and domestic drug or device facilities. By law, drugs and devices from facilities that refuse…
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inspection are deemed adulterated by the FDA, and barred from import. The new guidance supersedes guidance issued by the FDA in 2014, adding information on devices, among other things.