FDA 483 - Cdymax (India) Pharma Private Limited - April 25, 2025

Cydmax (India) Pharma Private Limited, an API manufacturer in Jigani, Bangalore, received a Form 483 with significant observations related to quality control, laboratory practices, and manufacturing controls. The inspection revealed critical issues including inadequate investigations into out-of-specification results, unvalidated test methods, deficient quality unit oversight, and poor contamination control during API manufacturing and equipment cleaning. These findings indicate a systemic lack of adherence to cGMP regulations, posing a risk to product quality and patient safety.