FDA 483 - Biological Research Solutions, Inc. - November 29, 2021

An FDA inspection of Biological Research Solutions, Inc., a control testing laboratory in Rochester Hills, MI, revealed significant deficiencies in its quality control unit. The firm failed to ensure that responsibilities and procedures were adequately written and followed, leading to issues with uncontrolled laboratory worksheets, unimplemented corrective actions, inadequate investigation procedures, and missing training records. These findings indicate a lack of robust quality system controls.