483
Amneal Pharmaceuticals, LLCFDA 483 - Amneal Pharmaceuticals, LLC - November 18, 2022
Record Details
An FDA inspection of Amneal Pharmaceuticals, LLC in Branchburg, New Jersey, a finished product manufacturer, revealed significant deficiencies in quality control and manufacturing processes. Observations included unrecorded deviations from production procedures, insufficient physical separation leading to potential cross-contamination, and a failure to thoroughly review unexplained discrepancies in laboratory testing. These issues indicate a need for improved adherence to established protocols and facility controls.
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ID · 7fee22fc-0cc6-4ca6-bb36-459b7511bd58