FDA EIR - MPI Research, Inc. - June 28, 2018

An FDA Good Laboratory Practice (GLP) surveillance inspection was conducted at MPI Research, Inc. in Mattawan, MI, from June 25 to June 28, 2018. This inspection, carried out under Compliance Program 7348.808 for nonclinical laboratories and referencing 21 CFR Part 58, identified five significant observations indicating non-compliance with GLP regulations. Key issues included unsuitable animal facility construction in certain corridors, where liquid waste accumulation posed contamination risks. The Quality Assurance Unit was found deficient in verifying authorized deviations from standard operating procedures, such as standing water during animal dosing and incorrect balance operation during necropsy. Furthermore, the Study Director failed to ensure accurate recording and verification of experimental data, specifically noting an inaccurately recorded animal dose time. The inspection also revealed that changes in automated data entries lacked proper explanations, with one instance of a body weight value being suppressed without a clear reason. Lastly, final study reports were found incomplete, omitting crucial information such as out-of-specification water analysis results that could affect data quality for housed animals. MPI Research management acknowledged the observations and committed to implementing necessary corrections.