You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time.

Because of this, your company must be prepared at all times.

In past articles, I’ve shared several ways in which you can plan ahead for inspections to ensure they go as smoothly as possible. But what if you’re past that point in the process? What if you get a knock on your door, and it’s a surprise visit from an inspector? I’m sure you’d like to know what will happen next, and what you should know in the moments after the shock and panic subside—both from an inspector’s point of view and your own.

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