Procedural, Documentation Issues Lead to Warning for CeraSys

CeraSys received a warning letter citing it for not listing a product and for a number of procedural and documentation failures in the manufacture of its zirconia dental blocks. The letter stems from an April 28 through May 4 inspection of the company’s Buena Park, Calif., facility. CeraSys responded to the Form 483 June 14, but the FDA refused to consider the response because it was submitted late. CeraSys is still dealing with the FDA to address the issues, a company spokeswoman said.
The GMP Letter