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FDLI Enforcement Conference In Brief

This article was originally published in The Tan Sheet

Executive Summary

Four signs an inspection is not going well: Firms undergoing an FDA inspection should be wary of problems if inspectors show up later every day during the process, says Raymond Bonner, a partner at Sidley Austin. During the first day of the Oct. 12-13 Food and Drug Law Institute conference in Washington, Bonner explained that inspectors who arrive later on subsequent inspection days "are probably not getting another round of pancakes," but rather are "coordinating with headquarters" on how to address issues they identified on previous days. Another sign an inspection is not going well is inspectors planning a re-inspection while conducting the initial audit, Bonner said. Other indications of problems are FDA dragging its feet on giving a firm an establishment inspection report and the agency not responding to requests to discuss a firm's response to a form 483 following an inspection. In cases where problems are likely, Bonner recommends firms engage with FDA immediately, "bring in a team that swarms the facility and jumps on" issues identified during the inspection and dedicate funds to correcting problems. Prompt response by firms could turn the confidence of FDA back in a company's favor, he said

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