FDA 483 - Anthea Pharma Private Limited - April 04, 2025

Anthea Pharma Private Limited in Hyderabad, India, was inspected and cited for significant deficiencies in quality control and aseptic processing. The firm failed to reject drug products with visible particulates, lacked adequate procedures to prevent microbiological contamination, and had insufficient written procedures for production and process controls. These issues indicate a serious lack of control over drug product quality and sterility assurance.