FDA WARNING_LETTER - Hikal Limited - February 07, 2025

Hikal Limited, a drug manufacturing facility located in Jigani, Karnataka, India, was inspected by the FDA from February 3 to February 7, 2025. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), leading to the classification of their APIs as adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations included the failure of the quality unit to adequately investigate and resolve quality-related complaints, particularly concerning metal contamination in APIs. The firm did not effectively determine the root cause of approximately 22 complaints since 2020, including issues with metallic particles in APIs. The FDA found that Hikal Limited"s metal detector was not adequately qualified to detect these particles, and their cleaning procedures were insufficient to prevent contamination.

Furthermore, the company failed to implement effective corrective and preventive actions (CAPAs) following numerous complaints of foreign material contamination. The risk assessment process was also criticized for being scientifically unsound. Additionally, Hikal Limited"s supplier qualification procedures were inadequate, as they did not include mechanisms for re-evaluating suppliers when quality deficiencies were detected.

The FDA has recommended that Hikal Limited engage a qualified consultant to address these CGMP compliance issues. The company is required to provide evidence of a comprehensive evaluation of contamination sources, process controls, and supplier performance, along with a robust root cause analysis of their supplier qualification system. The firm"s executive management is responsible for ensuring compliance with CGMP standards.