The European Medicines Agency (EMA) is calling on the European Commission to suspend the marketing authorization for Inductos, Medtronic's implant used to help new bone growth in patients with spinal disc problems and leg fractures.
The recommendation comes after a follow up inspection of a US manufacturing site was found to be "non-compliant with manufacturing requirements [and] did not have adequate measures in place to prevent particle contamination."
While EMA notes that there is "no indication of risk to patients linked to the inspection findings," the agency's Committee for Medicinal Products for Human Use (CHMP) says it cannot certify Inductos' quality in light of the inspection findings.
When reached for comment, Eric Epperson, spokesman for Medtronic, confirmed that EMA had "withdrawn the Good Manufacturing Practices (GMP) certificate at a plant for a third party manufacturer that supplies" one of Inductos' components.
Epperson went on to say Medtronic "is in regular contact with the" the third-party contract manufacturing organization (CMO) and is "working with them … to address the concerns raised by [EMA]. We expect their facility to be up and running soon."
He also emphasized that the issues pose "no risk to patients," and that Inductos kits already on the market include absorbable collagen sponges (ACS) that meet "EMA-approved product specification and all release criteria."
In July, EMA announced it was reviewing Inductos after Spanish and Dutch inspectors discovered contamination issues at a US site where one of Inductos' components is manufactured.
The site is operated by Integra LifeSciences, which manufactures the absorbable collagen sponge that is used alongside the product's active ingredient, dibotemin alfa.
In January 2014, after inspectors uncovered "a number of major deficiencies" at Integra's site, the company was handed a corrective action plan and restricted from importing the ACS to the EU until inspectors could return to "assess the progress in eliminating the major deficiencies."
When inspectors returned for a follow-up inspection in April 2015, they found Integra had not taken adequate steps to eliminate "contamination of ACS with particulate matter." As a result, the Netherlands issued a draft statement of non-compliance and notified the Commission and CHMP on 23 July 2015.
After receiving the Netherlands' statement of non-compliance, the Commission requested EMA review conduct a review of Inductos to determine if the inspections warranted any changes to the product's marketing authorization.