EMA Seeks Information on Medtronic Implant Following Inspection
The European Medicines Agency is seeking information on an implant sold by a Medtronic unit after inspectors determined that a U.S.-based supplier of an active substance for the product had deviated from good manufacturing practices.
Specifically, the EMA’s Committee for Medicinal Products for Human Use is asking Medtronic BioPharma, which is based in the Netherlands, how the findings from an inspection of an Integra LifeSciences facility in Plainsboro, N.J., affect the risk-benefit balance of InductOs, which is used to treat patients with spinal disc problems and leg fractures.
The implant kit includes a powder that contains dibotermin alfa, a solvent, as well as an absorbable collagen sponge, an excipient.
During the April inspection, investigators from the Netherlands and Spain found that the Intergra facility didn’t have adequate measures in place to prevent particle contamination of the sponges, which remain in the body until they are degraded. The investigators recommended that importation of InductOs into the EU be halted and Integra’s GMP certificate withdrawn.
The action could lead to a shortage of the product in the EU starting in October, the EMA says.
The findings follow a January 2014 inspection of the Integra facility that turned up numerous GMP violations. The main concerns were particulate contamination and sterility assurance, and the company created a corrective action plan that was rejected. It sent a new plan the following month that was accepted, with Integra receiving a restricted GMP certificate that was valid until January 2015.
A follow-up corrective action plan to the April inspection was received in June and subsequently rejected due to a lack of clarity on the nature and extent of the contaminants. “Metal fragments, salt residues, hairs and PVC fibers are identified, but for none of these the most likely source has been established,” according to a statement of noncompliance with GMP. No new GMP certificate was issued.
To assess whether a change to InductOs’ marketing authorization is needed, CHMP is reviewing the inspection findings on the product’s overall risks and benefits. The committee has asked Medtronic for a timeline of steps it intends to take to ensure the manufacturing of ACS will be GMP-compliant again, including specific measures Integra already has undertaken.
A Medtronic spokeswoman said that the company is working closely with Integra LifeSciences in an advisory capacity to develop an action plan to remediate the quality issues in a timely manner.
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