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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 more than likely going to be asked for," said Phil...

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