Updated March 22, 2011, 3:25 P.M. with material sourced from the FDA.
Terumo Cardiovascular Systems must pay the FDA $35 million and won’t be able to sell some of its products until it completes an FDA-approved plan to fix manufacturing problems at a plant in Ann Arbor, Mich.
The Terumo Corp. (TYO:4543) subsidiary said it agreed on the terms of a consent decree with the federal watchdog agency, including a $35 million fine payable to the FDA. The company must also correct deficiencies in the plant’s quality system; until then, the manufacture of numerous Terumo Cardiovascular products are prohibited or restricted.
No recall is involved, but the company still can’t sell its CDI 101 hematocrit/oxygenation saturation monitoring system or TenderFlow pediatric arterial cannula, according to Terumo.
The Ann Arbor-based company said it hopes to complete the improvement plan within two years, although the agreement is still subject to the approval of the U.S. District Court for Eastern Michigan.
FDA investigators observed violations of the agency’s current Good Manufacturing Practice and Medical Device Reporting requirements at the company’s manufacturing facility during an inspection from January through March 2010. The problems included “deficiencies in processes for corrective and preventive action, nonconforming product, complaints, purchasing, process validation, design controls and adverse event reporting,” the FDA said.
The FDA issued two warning letters to Terumo CVS about cGMP problems, once in 2004 and once in 2006, according to the agency.
"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," Terumo CVS CEO Mark Sutter said in prepared remarks.