FDA 483 - Amneal Oncology Private Limited - March 15, 2018

Amneal Oncology Private Limited in Hyderabad, India, was cited for significant deficiencies in its drug manufacturing facility. Observations included a lack of written production and process controls, inadequate quality control unit authority over data integrity, unrecorded deviations from procedures, and insufficient investigations into unexplained discrepancies. These issues indicate a serious lack of control over critical manufacturing and quality processes for sterile injectable drug products.