The European Medicines Agency (EMA) will be reviewing Medtronic’s InductOs following reports of contamination problems at a site that manufacturers one of the product’s components. InductOs is an implantable bone development product used in patients undergoing spinal fusion in the lower back and in surgeries to repair broken tibia. The kit InductOs is sold as contains its active ingredient dibotermin alfa and an absorbable collagen sponge (ACS) manufactured by Integra LifeSciences.
Regulatory Affairs Professionals Society (RAPS) reports that the contamination problems were from a site in the United States that manufactures the ACS in InductOs. In January 2014, inspectors identified “a number of major deficiencies” and Integra was issued a corrective action plan. Because of the contamination issues, the company was not allowed to import the sponge to the EU until inspectors could return and “assess the progress in eliminating the major deficiencies”.
When inspectors came back for follow-up in April 2015, they determined that the issues were still not resolved. They stated that Integra failed to eliminate “contamination of ACS with particulate matter”. These findings prompted the Netherlands to issue a draft statement of non-compliance in July 2015 and notify the European Commission (EC) and EMA’s Committee for Medicinal Products for Human Use (CHMP). On July 23rd, the draft statement of non-compliance was finalized. Afterwards, the EC asked the EMA to “assess the [issues] and their impact on the benefit risk balance for … InductOs” according to RAPS.
Following reports of contamination at the US site, the EMA will begin its review of InductOs and make recommendations for marketing authorization as needed. Meanwhile, the agency wants to ask Medtronic if there have been any “safety reports or complaints … related to the contaminating particulate matter,” and if there are “any patient population(s) for whom there is no other treatment option available.” Additionally, EMA wants Medtronic to provide a timeline of action to “ensure that the manufacturing of the ACS will be GMP compliant.”