FDA 483 - Alembic Pharmaceuticals Limited - November 22, 2024

Alembic Pharmaceuticals Limited in Jarod, India, received a Form 483 with five observations during an FDA inspection. The findings highlight significant deficiencies in manufacturing process control, including inadequate identification of critical process parameters and statistical evaluations. Additionally, issues were noted in quality control sampling, equipment cleaning procedures, analytical method validation, and data integrity within computer systems.