Unichem Laboratories said the US Food and Drug Administration (FDA) conducted an inspection of its Goa formulation facility in Pilerne, Bardez, from September 21 to 26, 2026.
According to the company, the inspection concluded with five observations related to procedural enhancements.
Unichem Laboratories said it will submit the necessary response to the US FDA within the stipulated 15-day period.
The company has not disclosed further details of the individual observations. The inspection outcome comes as part of the US FDA’s regulatory oversight of pharmaceutical manufacturing facilities supplying products to the US market.
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