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.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.