What to Do When the FDA Comes Knocking: A Guide to Surviving FDA Inspections for Small Businesses


This whitepaper from the experts at Thompson FDA provides critical, detailed information that small businesses need to know to successfully manage an FDA inspection.

Planning for an inspection long before it occurs, knowing the kinds of events that may lead the FDA to conduct an inspection, managing the inspection process while the agency investigator is at your facility, conducting the best follow-up after the inspection is completed, and (if needed) preparing a timely and thorough response to the FDA are all vitally important to ensuring that the inspection goes as well as possible — and to minimizing the chances for subsequent costly and distracting enforcement action by the agency.

The whitepaper explains the basics of an FDA inspection, outlines the respective rights of the agency and of your company, and provides details on various actions that can occur during the inspection. It also discusses the need to reach a common understanding within your company about the feedback from the agency inspector, as well as how to undertake the crucial task of preparing a prompt and appropriate response to the investigator’s observations.

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