Sun Phar­ma fa­cil­i­ty un­der an im­port alert hand­ed a warn­ing let­ter

A man­u­fac­tur­ing site be­long­ing to a ma­jor gener­ics man­u­fac­tur­er in In­dia has been giv­en a warn­ing let­ter from the FDA af­ter it was placed on an im­port alert.

The FDA’s let­ter, which was sent on Dec. 15, in­volves a 23-page Form 483 in­spec­tion in April and May of last year and its sub­se­quent re­sponse by Sun Phar­ma.

Dur­ing the FDA’s ini­tial in­spec­tion, sev­er­al vi­o­la­tions were not­ed, which in­clud­ed not ac­cu­rate­ly sim­u­lat­ing com­mer­cial op­er­a­tions and “poor asep­tic tech­niques.” These tech­niques in­clud­ed an op­er­a­tor in­sert­ing a gloved hand in­side a can­is­ter, some­one touch­ing the “prod­uct con­tact sur­face” of a stop­per be­fore plac­ing it back in­to a can­is­ter, and move­ments from the op­er­a­tors in “crit­i­cal ar­eas” not al­ways be­ing slow and de­lib­er­ate, among oth­ers.

Sun Phar­ma did pro­vide a re­sponse to the FDA on this sub­ject, but it was in­ad­e­quate for the US reg­u­la­tor.

“You ex­pe­ri­enced a sig­nif­i­cant me­dia fill fail­ure in No­vem­ber 2021, which re­vealed se­ri­ous flaws and risks in your op­er­a­tion. You failed to per­form a time­ly risk as­sess­ment to eval­u­ate if the qual­i­ty and steril­i­ty of your dis­trib­uted drug prod­ucts were af­fect­ed by these de­fi­cien­cies. You wait­ed over five months to ini­ti­ate a re­call of the af­fect­ed batch­es,” the let­ter said.

The warn­ing let­ter al­so not­ed the Halol fa­cil­i­ty had clean­rooms that were “poor­ly de­signed” and lack­ing ad­e­quate pro­tec­tion, as well as the man­u­fac­tur­er not per­form­ing en­vi­ron­men­tal mon­i­tor­ing in sev­er­al spaces.

In Sun’s re­sponse to the FDA, it ac­knowl­edged the in­ad­e­qua­cies of the en­vi­ron­men­tal and per­son­nel mon­i­tor­ing, stat­ing that the im­pact­ed prod­ucts are be­ing re­called and an ac­tion plan was pro­vid­ed. Sun al­so told the FDA it has a plan to map its man­u­fac­tur­ing process­es from a “con­t­a­m­i­na­tion pre­ven­tion per­spec­tive.” How­ev­er, Sun did not ex­plain how its qual­i­ty and op­er­a­tions man­age­ment will en­sure prop­er de­sign, con­trol and be­hav­ior dur­ing pro­duc­tion.

Im­prop­er clean­ing and main­te­nance were al­so brought up in the orig­i­nal in­spec­tion as well, with some “residue” be­ing vis­i­ble along with scratch­es and dents on “prod­uct con­tact sur­faces.” While Sun did pro­vide ex­pla­na­tions for these is­sues, it did not give the FDA in­for­ma­tion on how long the equip­ment had been used and no risk as­sess­ment was pro­vid­ed.

The FDA’s warn­ing let­ter said that the find­ings show that Sun Phar­ma does not “op­er­ate an ef­fec­tive qual­i­ty sys­tem in ac­cor­dance with CGMP.”

“In ad­di­tion to the lack of ef­fec­tive over­sight of pro­duc­tion op­er­a­tions to en­sure re­li­able fa­cil­i­ties and equip­ment, we found your QU (qual­i­ty unit) is in­suf­fi­cient­ly re­sourced or en­abled with au­thor­i­ty to car­ry out its re­spon­si­bil­i­ties. Fur­ther­more, in­ter­nal com­mu­ni­ca­tions and sys­tems were not im­ple­ment­ed by man­age­ment to en­sure all lev­els of the com­pa­ny can ef­fec­tive­ly iden­ti­fy ma­jor qual­i­ty risks, so they are prompt­ly es­ca­lat­ed to se­nior man­age­ment, when­ev­er need­ed,” the let­ter said.

It has al­so been rec­om­mend­ed that Sun bring in a con­sul­tant to get back in­to com­pli­ance. Sun Phar­ma did send a let­ter to the Na­tion­al Stock Ex­change of In­dia stat­ing that a warn­ing let­ter on the is­sues at the Halol plant would be re­leased, but did not pro­vide any de­tails on its re­sponse to the FDA or how it will get back in­to com­pli­ance.

The Halol plant was al­so giv­en an im­port alert in De­cem­ber, mean­ing that the FDA has enough ev­i­dence to de­tain prod­ucts with­out ex­am­i­na­tion and refuse their en­try in­to the US mar­ket from the fa­cil­i­ty un­til the is­sues are cor­rect­ed and are com­pli­ant with cGMP. Sev­er­al prod­ucts are now un­der the im­port alert, in­clud­ing an an­tibi­ot­ic, a biosim­i­lar and a slate of oth­er drugs meant for hu­mans and an­i­mals.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

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The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

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