FDA 483 - SMS Lifesciences India Limited - May 09, 2025

An FDA inspection of SMS Lifesciences India Limited in Kazipally Village, India, revealed a significant deficiency in their microbial testing procedures for water used in manufacturing active pharmaceutical ingredients. The firm failed to ensure that test procedures were scientifically sound and appropriate, specifically regarding sample size and method suitability for water microbial limits. This indicates a serious concern regarding the quality control of critical manufacturing inputs.