www.fdanews.com/articles/114184-warning-letter-requires-consultant-certifications
Warning Letter Requires Consultant Certifications
January 30, 2009
The FDA is requiring Haemonetics to have its manufacturing and quality assurance systems certified by an outside expert as part of a 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.
In the warning letter, the FDA cites the blood-processing technology company for failure to establish and maintain procedures for implementing corrective and preventive action. For instance, it opened a supplier corrective action (SCA) in December 2007 when it rejected four lots of a Level II control from a redacted supplier and received customer complaints of out-of-range results from approved lots. The SCA determined that the root cause was due to the “variability associated with characteristics of this abnormal control,” the FDA says.
The GMP Letter
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.
In the warning letter, the FDA cites the blood-processing technology company for failure to establish and maintain procedures for implementing corrective and preventive action. For instance, it opened a supplier corrective action (SCA) in December 2007 when it rejected four lots of a Level II control from a redacted supplier and received customer complaints of out-of-range results from approved lots. The SCA determined that the root cause was due to the “variability associated with characteristics of this abnormal control,” the FDA says.
The GMP Letter