The FDA recently announced that its inspectors may be knocking on your door as early as July 20 to conduct long-overdue domestic inspections. Once given the green light, inspectors’ first priority will be to conduct “mission critical” inspections of facilities considered to be of highest risk. But given the world we’re operating in, that actually means very little. In fact, we urge every company to prepare now as if you were FDA Priority #1.
We don’t know for sure what the FDA deems the most urgent risk. For example, the recently discovered hand sanitizer risks may have caused the agency to shift their priorities in the last couple of weeks. But the agency is also under intense pressure to crack down on produce packers, egg producers and pharmaceutical companies that may have cut corners as they sped up production to meet demand in recent months.
The good news is that, “for the foreseeable future,” the FDA will pre-announce inspections. Meaning, in most cases, you’ll get fair warning that inspectors are on their way. Whether that warning is 24 hours or 24 days, however, here are a few things to think about now:
We knew inspections would resume eventually. But now they are imminent for some companies. Is yours next?
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