FDA 483 - Amneal Pharmaceuticals Private Ltd. - April 24, 2018
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Amneal Pharmaceuticals Pvt Ltd. in Matoda, India, was inspected from April 16-24, 2018, and received a Form 483 for significant deficiencies in its quality control unit. The firm's quality control unit failed to adequately review raw data and deviations from contract laboratories for various tests, including method validations and API testing, before approving data and releasing products. This indicates a critical breakdown in oversight of outsourced testing and product release procedures.
ID · ca761aa3-3f67-47d0-8e0a-ec569a845796