GMP Warning to Devicemaker Sets Deadlines for Third-Party Audit

In a rare use of its powers, the FDA is requiring a California devicemaker to get a third-party audit of corrections relating to a slew of serious manufacturing and quality assurance deficiencies and verify the audit to the agency by March 1, 2014.

The request follows Medical Device Resource’s fourth warning letter in just over 13 years — the most recent letter being a hefty one with 15 citations — and shows the FDA’s lack of tolerance for companies that rack up multiple warnings. Some of the more serious citations include supplier evaluation shortfalls and risk-management failures.

The FDA only takes this type of action on “fairly rare occasions where the QSR deficiencies are severe and broad-based,” Neil O’Flaherty of Olsson Frank & Weeda said.

The company, which makes liposuction aspirator systems, is being asked to submit a copy of the consultant’s report, along with certification by its own CEO that he has reviewed the report and the company has begun or completed all corrections.

Subsequent certifications, if necessary, will be due each year by Sept. 1 for the following three years, according to the Sept. 20 letter posted online.

The FDA has made this type of request before, “albeit very sparingly,” Steven Niedelman, lead quality systems and compliance consultant with King & Spalding, said. “It is the format for recidivist warning letters; however, this letter is not titled as such.”

Niedelman said the FDA likely demands such action if it “has concerns and believes they rise to the significance of filing an injunction” and they believe an outside audit could help the company pull through.

According to the FDA’s warning letter database, the company previously received warning letters in October 2012, December 2007 and August 2004, with citations that include management review problems and documentation and validation deficiencies.

The new 15-citation warning letter covers a broad range of issues, including supplier management and risk analysis.

For example, by the time of the March 5 to May 6 inspection, the company had not evaluated its sterilization contractor for Aquavage devices. “Your firm identified the contractor as a critical supplier but failed to provide a vendor questionnaire or vendor survey as required by your firm’s vendor approval procedure,” the letter says. And the company’s vendor approval procedure does not clearly define the criteria for approval or the quality data to review when reevaluating a vendor.

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