FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has hand­ed Tor­rent Phar­ma­ceu­ti­cals an of­fi­cial ac­tion in­di­cat­ed (OAI) sta­tus for a pre­vi­ous­ly in­spect­ed man­u­fac­tur­ing fa­cil­i­ty in In­dia.

Tor­rent Phar­ma sent a let­ter to the Na­tion­al Stock Ex­change of In­dia ear­li­er this week with word that the man­u­fac­tur­er has re­ceived a “com­mu­ni­ca­tion from the FDA de­ter­min­ing the in­spec­tion clas­si­fi­ca­tion as ‘Of­fi­cial Ac­tion In­di­cat­ed’ (OAI)” for one of its sites. An OAI clas­si­fi­ca­tion from the FDA comes af­ter the agency has com­plet­ed an in­spec­tion and de­ter­mines if the fa­cil­i­ty com­plies with the ap­plic­a­ble laws and reg­u­la­tions. Be­ing giv­en an OAI clas­si­fi­ca­tion means that reg­u­la­to­ry or ad­min­is­tra­tive ac­tions will be rec­om­mend­ed to Tor­rent. How­ev­er, the de­tails on the rec­om­mend­ed ac­tions have not been giv­en.

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