USFDA inspection at Karakhadi Injectable Facility completed with 2 observations
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USFDA completed an unannounced cGMP inspection at Alembic Pharmaceuticals' Injectable Facility (F-3) at Karakhadi from February 9 to February 18, 2026. The inspection closed with two observations, none related to data integrity. The company will respond within the stipulated timeframe and reaffirmed its commitment to quality standards.
Relatively positive outcome with only 2 observations and no data integrity issues. US supply likely continues without major disruption.