OsteoSymbionics, a maker of cranial plate implants, is hoping to resolve a recent warning letter that cited problems with several manufacturing procedures early this year.

The Cleveland company is well on its way to addressing most of the issues, CEO Cynthia Brogan said. The warning letter stems from an Oct. 13 inspection, the first the 3-year-old devicemaker has had.

During the inspection, an FDA investigator noted that several design controls for the development of the implant were inadequate. For instance, OsteoSymbionics failed to establish design inputs, as well as a design and development plan. It also did not fully implement its design verification procedure or validate the implant design, the letter says.
The GMP Letter