by Tony Chen

Yet another consent decree was announced today by the FDA. This time, it is Terumo Cardiovascular Systems, makers of heart machines that circulate blood during heart surgery.  Signed by Terumo’s CEO and Vice President of Quality Assurance, the consent decree:

“prohibits the company from manufacturing and distributing two heart-lung bypass systems and other cardiovascular devices to new customers.The consent decree also restricts sale of these systems to existing customers until TCVS complies with the FDA’s current Good Manufacturing Practice (cGMP) and Medical Device Reporting (MDR) requirements”

On top of that, the company has to pay $35 million in back profits.

A quick look at Terumo Cardiovascular Systems Form 483s shows one from March 2010, and then August 2008, March 2006, December 2005, May 2004, and then four from 2000.

“Terumo CVS is committed to fully addressing all of the FDA’s concerns.  Over the past year, Terumo CVS had already begun implementing a significant quality system initiative that will create systemic, sustainable improvements in its Quality Systems,” said Mark Sutter, President & Chief Executive Officer, Terumo CVS in their press release.  “Terumo CVS has always been, and will remain, committed to those in the cardiac surgery community who use our products.  Our ultimate goal during the consent decree is minimizing the inconvenience or disruption to our customers.”  For more coverage on this consent decree, check out the article on MassDevice.

The FDA has warned many times that they expect quality assurance professionals to monitor the happenings of their peers and not wait for the FDA to show up to correct similar deficiencies.  One of the best ways to do this is to obtain FDAzilla’s “Top Seven Strategies for Avoiding 483s” Report.  We synthesized 1,000+ recent 483 observations and dozens of expert interviews in this 31-page report.  But the bottom line is that there are key cGMP issues that keep on coming up again and again.  Like my basketball coach used to say, it’s all about the fundamentals – documentation, validation of software and equipment, and training (and the documentation of such training) among other things.

In other consent decree news:

  • Genzyme already has their 3rd party in place (30 people across their various sites) to oversee and review changes to bring their site back on track.
  • McNeil also has their consultants in place.  The CEO noted that the plant in question has been gutted, being renovated, and should be ready to go again by the end of the year.

In our opinion, the best way to avoid a consent decree is to avoid a warning letter.  The best way to avoid a warning letter.  The best way to avoid a warning letter is to avoid a 483.  The best way to avoid 483s is to read our 10 best resources for avoiding FDA 483s.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.