Warning Letter Requires Consultant Certifications

The FDA is requiring Haemonetics to have its manufacturing and quality assurance (QA) systems certified by an outside expert as part of its warning letter concerning GMP issues with the Massachusetts-based company’s thromboelastograph devices and accessories. The FDA says it must receive the initial certification by June 1 along with a certification from the company’s CEO stating he has reviewed the consultant’s report and Haemonetics has initiated or completed all indicated corrections. The agency asks for subsequent certifications by June 1, 2010.
The GMP Letter