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Patricia O'Connell
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Sonali Gunawardhana Discusses FDA Enforcement for Medical Device Makers

Bloomberg BNA
March 20, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted today in a Bloomberg BNA article about the potential areas of liability medical device manufacturers face in 2013.

Ms. Gunawardhana was among speakers at a March 4 Food and Drug Law Institute conference who pointed to increased enforcement activity by the U.S. Food and Drug Administration (FDA). The agency is issuing a growing number of warning letters to device makers over violations of the agency’s Quality System Regulation (QSR) and Current Good Manufacturing Practices (cGMP) requirements, according to the article.

While “FDA does not look at warning letters as punitive action ... if you’ve received one, they feel punitive,” and can put your company in a holding pattern, Ms. Gunawardhana said. “You can’t export product until you take corrective action, and it can be tough for a device company, especially if they just have one product.”

The FDA’s main areas of concern regarding cGMP violations are lack of written Medical Device Reporting (MDR) procedures, problems with companies’ handling of complaints, inadequate corrective action and preventive action procedures, inadequate process and design changes, and failure to maintain device history records (DHR), she said.

Noting that most inspections by the agency are for cGMP violations, Ms. Gunawardhana said companies should make copies of anything an FDA field inspector copies. Having copies of those documents will help a company respond to the agency later, she said.

Device makers must understand their supply chains and revisit their quality procedures often, because the FDA will hold them responsible for any supplier errors, she added.

Corporate officers can face civil and criminal liability for cGMP violations, Ms. Gunawardhana said. Consent decrees and criminal prosecutions generally name individuals as well as the corporation itself.

“When FDA inspectors come out, they’re looking for who the responsible person is,” she said. “If they can tie it back to you, you’re going to be individually named.”