FDA 483 - Sun Pharmaceutical Industries, Inc. - April 18, 2025

The FDA inspection of Sun Pharmaceutical Industries, Inc. revealed significant deficiencies across multiple areas, particularly concerning quality control and facility maintenance. The firm failed to thoroughly investigate numerous complaints, equipment failures, and out-of-specification results, impacting both sterile and non-sterile drug products. Additionally, issues were identified with unclean equipment, unmaintained facilities, inadequate water systems, and poor control over materials and labeling.