Concord Biotech announced that the US Food and Drug Administration (US FDA) has completed an inspection of its formulation facility located at Unit II–297–298/2p, at. Valthera, Tal. Dholka, Dist. Ahmedabad, Gujarat.
According to the company, the inspection concluded with one minor procedural observation, which it stated is not related to Good Manufacturing Practices (GMP).
Concord Biotech said it will submit a comprehensive response to the observation within the stipulated timeline.
The company did not provide further details on the nature of the procedural observation.
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