What FDA might consider as delaying or denying an inspection: New guidance spells out the specifics
The FDA is reworking how it evaluates certain behaviors (actions, inactions, and circumstances) that the FDA may consider to be delaying, denying, or limiting a drug or device inspection.
Building off a 2014 guidance on the same subject, which didn’t include devices, the revised draft guidance recognizes that inspection delays can occur for many reasons that may be out of the facility’s control, but when an owner, operator or agent causes the “unreasonable delay of an inspection,” this can cause the manufactured drugs or devices to be considered “adulterated.”
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