Sun Phar­ma site hit with sec­ond Form 483 in 3 years

An In­di­an phar­ma with a man­u­fac­tur­ing site in Gu­jarat has been slapped with a Form 483 from the FDA af­ter in­spec­tions that end­ed yes­ter­day re­sult­ed in 10 ob­ser­va­tions.

The in­spec­tion was car­ried out from April 26 to May 9 at Sun Phar­ma’s Halol fa­cil­i­ty in Gu­jarat, and shares were down 3% fol­low­ing the re­lease of the news. The de­tails of the ob­ser­va­tions have not yet been re­vealed.

“The com­pa­ny is prepar­ing the re­sponse to the ob­ser­va­tions, which will be sub­mit­ted to the US FDA with­in 15 busi­ness days,” Sun Phar­ma said in a let­ter to the Na­tion­al Stock Ex­change of In­dia. “The com­pa­ny is com­mit­ted to ad­dress­ing these ob­ser­va­tions prompt­ly. The com­pa­ny re­mains com­mit­ted to work­ing close­ly with the US FDA and con­tin­ues to en­hance its GMP com­pli­ance on an on­go­ing ba­sis.”

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