Granules India’s Gagilapur facility warrants regulatory action, the USFDA says

Granules India Ltd. has informed the exchanges on Tuesday, December 3, that the company’s Gagilapur facility in Telangana, has been classified as Official Action Indicated (OAI) by the United States Food and Drug Administration (USFDA).

In September this year, the USFDA had issued a form 483 with six observations for the Gagilapur facility.

An Official Action Indicated or OAI status means that a facility has objectionable conditions or practices that require regulatory or administrative action.

During the September quarter earnings call, the management had indicated a resolution of the facility by December.

“The company has responded to all the observations issued by the USFDA. Additionally, the company has voluntarily undertaken a comprehensive evaluation of the facility for further enhancements that lead to improvement of the facility,” Granules India said in its statement.

In September, CNBC-TV18 had accessed the form 483 issued to Granules’ Gagilapur unit.

Some of the violations included equipment and utensils not cleaned at appropriate levels, Responsibilities and procedures applicable to quality control unit not in writing, fully followed among others.

Shares of Granules India are down to the lowest point of the day, declining 8% to ₹543.75 post the announcement.