483
Roche Molecular Systems, Inc.Roche Molecular Systems, Inc. – FDA 483, Dec 8, 2023
Record Details
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.
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ID · a25a7c49-4521-4b0a-813b-71436327812d
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