Unichem Labs' Kolhapur API Facility Gets 5 USFDA Observations
New Delhi: Unichem Laboratories Limited has informed that the United States Food and Drug Administration (USFDA) has concluded an inspection of the company's Kolhapur active pharmaceutical ingredient (API) manufacturing facility with five observations, all of which were procedural in nature and not related to data integrity.
In a regulatory filing dated February 2, 2026, Unichem Laboratories Limited stated that the USFDA carried out the inspection at its Kolhapur API facility from January 27, 2026, to February 2, 2026. The inspection closed with five observations, which the company clarified were mainly linked to procedural aspects.
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The company emphasized that none of the observations raised by the USFDA were related to data integrity, an area considered critical during regulatory inspections of pharmaceutical manufacturing sites. Unichem Laboratories also assured that it will submit its responses to the USFDA within the stipulated timeline of 15 days.
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