FDA warn­ing let­ters de­tail is­sues for man­u­fac­tur­ing sites in the US and In­dia

The FDA this week re­leased new warn­ing let­ters for drug man­u­fac­tur­ers in the US and In­dia fol­low­ing the dis­cov­ery of sev­er­al qual­i­ty is­sues.

One warn­ing let­ter was hand­ed to Fort Worth, TX-based Sov­er­eign Phar­ma­ceu­ti­cals last month which de­tailed that the site had “failed to val­i­date the man­u­fac­tur­ing process” for an undis­closed tablet, as some of the ac­tive in­gre­di­ents were out-of-spec­i­fi­ca­tion.

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