FDA 483 - Alchymars ICM SM Private Limited - October 19, 2018

An FDA inspection of Alchymars ICM SM Private, Limited, an API manufacturer in Alathur, India, revealed extensive deficiencies across its quality, laboratory, production, and facilities systems. Significant issues include widespread data integrity problems with chromatographic software, falsified training records, an inadequate stability program, and poor facility maintenance with unsanitary conditions. These findings indicate a critical lack of control over manufacturing and quality processes, posing a risk to product quality and safety.