SNBL USA has received a response from the FDA indicating that SNBL has remedied process deficiencies specified in a September 2011 warning letter. “All remaining reporting requirements will be finished quickly,” said Dr. Thomas Beck, president and chief operating officer of SNBL. “We remain confident SNBL is performing at a level that will produce high-quality, GLP-compliant work.”
The warning letter specified nine items, of which seven have been completely resolved. The remaining two items require SNBL to finalize several report amendments regarding specific assay issues on certain past studies. To remedy the issues, the company conducted thorough GLP trainings for all staff members and has rebuilt the operation to reestablish its ability to provide preclinical drug development services.
“We attribute this success to several key initiatives that will carry us into the future and strengthen our processes and compliance,” said Dr. Beck. These initiatives include top management changes and restructuring, an expanded QAU department, enhanced training program and documentation, GLP- and Part 11-compliance training and competency testing, continuous SOP writer training courses to enhance quality of processes, a dedicated group to schedule and monitor timelines, and enhanced programs to monitor equipment maintenance and calibration.
“We are pleased the recent FDA response reflects the systemic changes and process improvements we have made over the past year. All of us at SNBL USA have worked diligently to reestablish the quality systems and reliable data that made SNBL USA the CRO of choice for primate research,” said Dr. Beck.