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

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.

While Sov­er­eign claimed that it launched an in­ves­ti­ga­tion in­to the mat­ter, the FDA felt that its re­sponse was not suf­fi­cient.

“Your firm did not pro­vide suf­fi­cient da­ta to show where vari­abil­i­ty in your process was oc­cur­ring. Your man­u­fac­tur­ing process fail­ures in­di­cate that you do not have an ad­e­quate on­go­ing pro­gram for mon­i­tor­ing process con­trol to en­sure sta­ble man­u­fac­tur­ing op­er­a­tions and con­sis­tent drug qual­i­ty,” the let­ter said.

The FDA al­so saw dur­ing its ini­tial ob­ser­va­tions that the site’s qual­i­ty unit was not “ef­fec­tive­ly ex­er­cis­ing its re­spon­si­bil­i­ties to over­see the qual­i­ty of your drug man­u­fac­tur­ing op­er­a­tions,” as writ­ten pro­ce­dures were not be­ing fol­lowed.

“You failed to pro­vide suf­fi­cient da­ta to show that your sta­bil­i­ty sam­ples were not neg­a­tive­ly im­pact­ed by the ex­cur­sions list­ed in the ob­ser­va­tion. In ad­di­tion, you did not per­form a ret­ro­spec­tive re­view for oth­er po­ten­tial sim­i­lar ex­cur­sions to take ap­pro­pri­ate CA­PAs and prod­uct im­pact eval­u­a­tions. You al­so failed to per­form a com­pre­hen­sive re­view of sim­i­lar­ly im­pact­ed sys­tems by a de­fi­cient QU,” the let­ter said.

In­dia-based gener­ics gi­ant Lupin was al­so hit with a warn­ing let­ter for its plant in Tara­pur, In­dia, with the let­ter un­veil­ing that the com­pa­ny had not es­tab­lished writ­ten pro­ce­dures for clean­ing equip­ment for man­u­fac­tur­ing APIs.

Lupin had no­ti­fied the In­di­an stock ex­change of the let­ter in ear­ly Oc­to­ber.

FDA re­vealed that Lupin al­so didn’t have writ­ten pro­ce­dures to mon­i­tor the progress of “pro­cess­ing steps” that may cause “vari­abil­i­ty” in the qual­i­ty of the in­gre­di­ents as well as not prop­er­ly in­ves­ti­gat­ing all “crit­i­cal de­vi­a­tions.”

Ac­cord­ing to the let­ter, the com­pa­ny had sus­pend­ed the pro­duc­tion of drugs for the US mar­ket and must no­ti­fy the FDA if it wants to restart mak­ing drugs for the US.

Both com­pa­nies had 15 days to re­spond to the FDA or risk fur­ther penal­ties.