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Concord Biotech Gujarat Plant Gets One US FDA Observation

Concord Biotech Gujarat Plant Gets One US FDA Observation

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. 

More news about: quality / gmp | Published by News Bureau | September - 19 - 2026

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