FDA 483 - Roche Molecular Systems, Inc. - December 08, 2023

Roche Molecular Systems, Inc. in Branchburg, NJ, received a Form 483 with two observations. The firm failed to report a biological product deviation for an IVD kit with internal control invalidations caused by a software error during the filling process. Additionally, the firm did not adequately evaluate a supplier, which resulted in numerous customer complaints about leaking reagent bottles.