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Want A Quick Inspection? Have Records Prepped And Don't Dilly-Dally When Asked For Documents, FDA Investigators Advise

When 86 percent of FDA domestic inspections are preannounced, it's difficult to imagine that manufacturers could be caught unprepared – yet many do not have the appropriate records ready for investigators when they knock on the front door. And an auditor's suspicion might be aroused when it takes a long time to retrieve a particular document, says investigator Laureen Geniusz, who recommends manufacturer transparency: "If the record is stored in a cave in Pennsylvania, let the investigator know that's why it’s going to take a while to get it."

The best way for a company to expeditiously move a nosy FDA investigator through each step of a facility inspection is to be prepared, FDA officials say. That means pulling all relevant records and not playing hide-and-seek with documents requested by the agency.

"Firms know we follow the QSIT approach during an inspection. So there are certain records and certain procedures that are...

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