Preparation, Honesty Keys to Avoiding Red Flags for InspectorsPreparation, Honesty Keys to Avoiding Red Flags for Inspectors

Originally Published MDDI March 2004

NEWSTRENDS

Erik Swain

An FDA site inspection will go a lot more smoothly for a device company if it communicates honestly, directly, and clearly with the inspector, according to an expert.

Jim Kozick is director of medical device compliance services for KMI, a division of Parexel International LLC (San Clemente, CA) and a former FDA inspector. There are a number of simple things for device companies to keep in mind that will improve relations with the agency, he said. He made his remarks at the Medical Design & Manufacturing West conference, held in January in Anaheim, CA.

First, he said, employees need to be prepared before the inspection. Firms should have an inspectional standard operating procedure, train workers on interview skills and body language, identify who can speak with expertise about which topics, and conduct mock inspections so that employees know what to expect. It is also vital that previous inspectional issues be corrected, he said, because what upsets FDA more than almost anything else is the failure to address issues it has already made a company aware of.

Upon the inspector's arrival, he or she should be asked the purpose of the inspection, the expected duration of it, which operations will be looked at, and his or her planned daily schedule, so the most knowledgeable staff can be made available at the appropriate times. Also important is to ask what types of records will be needed. “Don't make them ask twice,” he said.

It is also a good idea to request a daily debriefing on issues because “not everything is black and white,” Kozick said. “Investigators often send clear signals on what they are concerned about, especially if they keep asking the same questions, or reword the same kind of question.”

It is extremely important that firms tell the truth, but almost as crucial is the way it should be told, he said. Personnel should answer the question that is asked, and not vacillate or try to change the subject, because if that happens, “you plant the seed of suspicion.” At the same time, workers should not provide information in excess of what is requested, because they may confuse the issue or mistakenly provide information that the agency is not entitled to. If someone is asked a question for which they do not know the answer, they should refer it to someone who would know rather than try to make up an answer. Offering to demonstrate how a product works, on the other hand, can clarify matters.

Proper interpersonal relations can also help, Kozick said. Maintaining a courteous, professional attitude should be encouraged, while keeping the investigator waiting, using diversionary tactics, and making condescending or confrontational remarks should be discouraged. “There is a professional way to disagree,” he said.

Device firms often neglect postinspectional communication, which is a mistake, he said. If any deficiencies are cited, “write to the district director immediately of your plans, and give a date by which you expect to have them resolved,” he said. Importantly, though, deficiencies should be addressed system-wide, and preventive action as well as corrective action should be taken. Relations with an inspector will take a turn for the worse if the same deficiencies recur during subsequent inspections. “You have to address the underlying cause of the observation, support your statements with data, update FDA on the status of your actions, and reiterate a commitment to compliance,” he said. “Recurrent high-level departures from QSRs or lack of management commitment to QSRs is a red flag.” 

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