Cochlear's Australian facility placed on import alert, reinspection expected in June.
This article was originally published in The Gray Sheet
Executive Summary
COCHLEAR CORP. AUSTRALIAN FACILITY REINSPECTION BY FDA is expected before the end of June, the firm says. Cochlear is confident that corrective actions taken at its Lane Cove, Australia facility -- the sole manufacturing site for the firm's Nucleus 22 Channel cochlear implant system -- will be sufficient to convince the agency to lift its prohibition in importing devices from the facility.