FDA 483 - MET Research, Inc. - April 15, 2016

An FDA inspection of MET Research, Inc. in Mattawan, MI, a non-clinical laboratory, revealed significant issues with data integrity, record keeping, and final study report accuracy. Observations included failures in archiving raw data, discrepancies between raw data and final reports, and omissions of key personnel from study reports. Two of the three observations were repeat findings from a previous inspection, indicating persistent problems.