The FDA reported finding "objectionable conditions" during an Aug. 23-Sept. 22, 2010 inspection of the company's facility. The warning letter also states that the company failed to submit an IDE application and receive FDA approval prior to allowing patients to participate in a study of the Xclose soft tissue repair system for annulus fibrosus repair. Additionally, the FDA cited Anulex for promoting Xclose for annulus fibrosus repair before FDA approval for commercial distribution.
Anulex president and general manager Tim Miller denies having prior knowledge of needing to obtain an IDE, according to Fierce Medical Devices.
The company has stopped Xclose marketing for spinal procedures, which led to the layoffs.