Granules India has announced an update regarding the US Food and Drug Administration (US FDA) inspection of its Gagillapur facility in Hyderabad, Telangana. The inspection, completed earlier in September, resulted in the issuance of Form 483 with six observations.
The US FDA has now classified the inspection as “Official Action Indicated” (OAI). In response, Granules India has submitted detailed responses to address the observations. The company has also voluntarily undertaken a comprehensive evaluation of the facility, aimed at enhancing its standards in consultation with external subject matter experts.
Granules India stated its intent to work closely with the US FDA on these measures. The company expressed confidence that these efforts will align the facility with the US FDA’s compliance expectations in a timely manner.
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