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

The U.S. Food and Drug Administration (FDA) conducted an inspection of SMS Lifesciences India Limited, Unit-I, in Sangareddy, Telangana, India, from May 5 to May 9, 2025. This inspection resulted in the issuance of a Form 483 observation, detailing significant deficiencies in the firm's quality control processes for purified water, essential for manufacturing Active Pharmaceutical Ingredients (APIs) for U.S. distribution.The primary violation cited was the failure to ensure scientifically sound and appropriate test procedures for purified water to meet established specifications. Specifically, the microbial testing of the water was found inadequate. Investigators noted that the approximate 1 ml sample size used for microbial limit testing was not proven appropriate for the high-volume water system (approximately [redacted] gallons per minute) to yield statistically valid colony counts. Additionally, the company had not conducted method suitability studies to verify the testing procedure's ability to recover microorganisms.Given that this purified water is used in manufacturing U.S.-marketed APIs and for cleaning equipment, the observations indicate potential deviations from Current Good Manufacturing Practice (CGMP) regulations. SMS Lifesciences India Limited is required to respond to these findings by developing and implementing robust corrective and preventive actions, which must be submitted to the FDA to ensure product quality and patient safety.