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Micro Orgo Chem, an active pharmaceutical ingredient (API) manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their APIs adulterated. The FDA inspection (April 11-18, 2024) identified critical failures including inadequate validation of cleaning procedures for non-dedicated equipment, failure to collect and test required rinse and swab samples, and poor equipment maintenance creating cross-contamination risks. The company acknowledged that sanitary conditions in manufacturing and laboratory areas were not maintained to required standards and committed to a voluntary recall of all APIs shipped to the U.S. market.