FDA 483 - Centrient Pharmaceuticals India Private Limited - January 27, 2026

Centrient Pharmaceuticals India Private Limited in Toansa, India, received a Form 483 with three observations related to significant manufacturing deficiencies. The inspection revealed severe issues with equipment cleaning, leading to cross-contamination and residual materials, as well as failures in preventing contamination of APIs by foreign particles from worn equipment and inadequate environmental monitoring. These issues pose a substantial risk to product quality and patient health.