FDA warns Strides Phar­ma for un­con­trolled doc­u­ment shred­ding

The FDA warned In­di­an gener­ic drug­mak­er Strides Phar­ma ear­li­er this month over good man­u­fac­tur­ing prac­tice (GMP) vi­o­la­tions at its Puducher­ry fa­cil­i­ty that in­clud­ed un­con­trolled shred­ding of doc­u­ments and in­ad­e­quate in­ves­ti­ga­tions in­to out-of-spec­i­fi­ca­tion (OOS) test re­sults.

In a se­cu­ri­ties dis­clo­sure is­sued on 2 Ju­ly, Strides ac­knowl­edged re­ceiv­ing the warn­ing let­ter but said that the let­ter will not im­pact pro­duc­tion of six FDA ap­proved gener­ic drugs made at the site, but that 10 ab­bre­vi­at­ed new drug ap­pli­ca­tions (AN­DAs) await­ing FDA ap­proval “will get de­ferred till the site is re­clas­si­fied.”

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.