FDA 483 - Metrex Research, LLC. - May 20, 2022

Metrex Research, LLC. in Romulus, MI, was inspected and cited for multiple significant deficiencies in their manufacturing processes for drug products. Key issues include inadequate microbiological testing of non-sterile drug products, unvalidated water system testing, poor computer system controls leading to data integrity concerns, and insufficient equipment maintenance and cleaning validation. These observations indicate a lack of robust quality control and assurance practices.