USFDA inspection at Kolhapur API facility closed with 5 procedural observations
UNICHEMLAB · price
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USFDA inspected Unichem Labs' Kolhapur API facility from 27 Jan to 2 Feb 2026. The inspection closed with five observations, all described as procedural in nature, with none related to data integrity. The company will submit its response to USFDA within the stipulated 15 days.
Reassuring outcome since observations are procedural only and no data integrity issues flagged; Kolhapur facility supplies the US generics market.