CDYMAX (INDIA) PHARMA PRIVATE LIMITED – FDA 483, Feb 28, 2025

Cdymax (India) Pharma Private Limited, a drug manufacturer in Bangalore, India, was cited for deficiencies in laboratory records during an FDA inspection. The observations primarily concern incomplete data from tests, examinations, and assays, specifically regarding microbial enumeration test method suitability and inadequate isolate identification for both raw material monitoring and environmental monitoring in production areas. These issues indicate a lack of assurance in compliance with established specifications and standards.