In­di­an man­u­fac­tur­er hit with Form 483 — again

An In­dia-based gener­ics man­u­fac­tur­er is once again feel­ing the wrath of US reg­u­la­tors.

Au­robindo Phar­ma has been slapped with a Form 483 fol­low­ing an in­spec­tion of the com­pa­ny’s oral man­u­fac­tur­ing fa­cil­i­ty, the com­pa­ny an­nounced in a let­ter, while keep­ing the de­tails to a min­i­mum.

The fa­cil­i­ty is lo­cat­ed in Jad­cher­la, In­dia, out­side of the city of Hy­der­abad. The in­spec­tion be­gan last week, and con­clud­ed on Tues­day, ac­cord­ing to Au­robindo. The FDA not­ed six ob­ser­va­tions, though it’s still un­clear ex­act­ly what went wrong.

Form 483 is is­sued when in­spec­tors ob­served “any con­di­tions that in their judg­ment may con­sti­tute vi­o­la­tions of the Food Drug and Cos­met­ic (FD&C) Act and re­lat­ed Acts,” ac­cord­ing to the FDA.

“The Com­pa­ny will re­spond to the US FDA with­in the stip­u­lat­ed time­line and work close­ly with US FDA to close the ob­ser­va­tions,” Au­robindo said in the let­ter.

The in­spec­tion is cer­tain­ly not help­ing Au­robindo’s stock price $AU­ROPHAR­MA which fell over 2% to­day and has dropped more than 20% in the past year.

How­ev­er, this is not the first time the com­pa­ny has found it­self in the FDA’s crosshairs. The com­pa­ny has re­ceived 14 oth­er 483 forms for dif­fer­ent man­u­fac­tur­ing sites in Telan­gana state since 2016.

In April of this year, FDA in­spec­tors closed Au­robindo’s Day­ton, New Jer­sey site, elim­i­nat­ing 99 jobs in the process. The site re­ceived a ma­jor warn­ing let­ter in 2020, re­veal­ing that the com­pa­ny’s staff had failed to in­ves­ti­gate un­ex­plained dis­crep­an­cies or fail­ures in API batch­es and left wa­ter leaks in pack­ing rooms, where am­bi­ent mois­ture can po­ten­tial­ly con­t­a­m­i­nate APIs. The com­pa­ny was al­so ac­cused of fail­ing to iden­ti­fy im­pu­ri­ty re­sults from con­t­a­m­i­na­tion due to mor­tar.

Au­robindo’s prod­ucts have al­so been the tar­get of sev­er­al FDA re­calls. Back in Feb­ru­ary, the com­pa­ny had to re­call more than 1.15 mil­lion bot­tles of Mox­i­floxacin Oph­thalmic So­lu­tion — an an­tibi­ot­ic used to treat eye in­fec­tions like bac­te­r­i­al con­junc­tivi­tis — due to failed im­pu­ri­ties and degra­da­tion spec­i­fi­ca­tions, ac­cord­ing to The Eco­nom­ic Times.  And in Jan­u­ary, Au­robindo vol­un­tar­i­ly re­called a lot of polymyx­in B for in­jec­tion af­ter a hair was found in a vial with­in the lot. That an­tibi­ot­ic is used to treat menin­gi­tis, pneu­mo­nia, sep­sis, and uri­nary tract in­fec­tions.

The FDA al­so is­sued a warn­ing let­ter to the com­pa­ny in Jan­u­ary for an­oth­er drug man­u­fac­tur­ing fa­cil­i­ty in Telan­gana state in con­nec­tion with a pre­vi­ous in­spec­tion. The let­ter cit­ed de­vi­a­tions from cur­rent good man­u­fac­tur­ing prac­tices for API.

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