FDA 483 - Alchymars ICM SM Private Limited - December 04, 2025

An FDA inspection of Alchymars ICM SM Private Limited in Alathur, India, revealed significant deficiencies in equipment maintenance, laboratory controls, cleaning validation, and facility upkeep. The firm failed to maintain manufacturing equipment in good repair, lacked proper data integrity for laboratory records, and did not adequately validate cleaning processes. Additionally, the facility suffered from water condensation issues, and production investigations were found to be insufficient.