Granules India Ltd. on Tuesday said that the US Food and Drug Administration has issued ‘official action indicated’ classification for its Hyderabad-based facility.
The USFDA’s OAI classification indicates that a facility is in “an unacceptable state of compliance”, according to the US drug regulator’s website.
Earlier, in September, the company had informed stock exchanges that the USFDA had completed its inspection at the Hyderabad plant with six observations. This inspection by the USFDA was conducted between Aug. 26 and Sept. 6.
In Tuesday’s exchange filing, the company also said that in addition to responding to all the observations issued by the USFDA, it has voluntarily undertaken a comprehensive evaluation of the facility for further enhancements that lead to improvement of the facility. This activity is undertaken in consultation with external subject matter experts.
The Hyderabad-based pharmaceutical major reiterated that it will work with the USFDA to comply with its expectations.
