FDA 483 - Amneal Pharmaceuticals LLC - November 28, 2018

Amneal Pharmaceuticals LLC, a drug packager in East Hanover, NJ, received two observations during an FDA inspection. The firm was cited for not having adequate written procedures for production and process controls, specifically regarding packaging process performance qualifications. Additionally, the inspection found that equipment and utensils were not cleaned at appropriate intervals, as the cleaning validation study failed to include worst-case dirty conditions.