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Elizabeth Kempen, senior vice president at Alquest Inc.

For medical device manufacturers, an FDA inspection can be a source of considerable anxiety. Although the intricacies of regulatory statutes can create confusion, good organization and a carefully constructed inspection plan can help companies safely navigate through an FDA audit, Elizabeth Kempen, senior vice president at Alquest Inc. (Minneapolis), told a Wednesday morning audience at MD&M West.

Historically, FDA used a bottom-up approach to inspections, looking for specific problems that pointed to failure in the quality system. However, budget and time constraints have led FDA to adopt the quality system inspection technique (QSIT). Under QSIT, the review focus shifts to a company's quality systems first, before specific problems are looked at in detail.

As a result, said Kempen, the FDA inspection process should begin well before an investigator shows up at a company's facilities. “The support of one or more senior managers is essential,” she said. “Without this, building a quality system is not going to work.” In addition, a company needs to keep its documents updated. “It's easier to maintain the system than it is to correct the system,” she said.

Because regulated facilities must be inspected every few years, a company should be ready for an audit at any time. Managers should examine the quality systems regularly to identify anomalies and correct any issues cited by FDA in previous inspections. During an audit, investigators need to ensure that a company is controlling product quality. As a result, remedies for product variability should be included in a company's standard operating procedures.

During the inspection itself, a company needs to remain in control. Documents should be organized and available if an FDA inspector requests them. Similarly, all employees involved in the FDA inspection team should be familiar with the company's code of conduct. One essential rule, said Kempen, is to answer only the questions presented by investigators. “Never volunteer information. This is one of the greatest challenges for management, especially given the desire to speak positively about the company,” she said. “Speak in specifics and narrow down general questions. Remain composed and work with the inspectors to ensure a successful inspection.”