Centrient Pharmaceuticals India Private LimitedJanuary 27, 2026

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

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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.

Company: Centrient Pharmaceuticals India Private Limited
Inspection Date: January 27, 2026
Product Type: Drugs
Office: Office of Inspections and Investigations
People: Pratik S. Upadhyay
Nibin Varghese

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