Form 483 cites Lupin man­u­fac­tur­ing site in In­dia for con­t­a­m­i­na­tion and oth­er qual­i­ty con­trol ob­ser­va­tions

The FDA has had its eye on the phar­ma­ceu­ti­cal man­u­fac­tur­er Lupin for a while, and now an­oth­er fa­cil­i­ty for the com­pa­ny has been in­spect­ed by the US reg­u­la­tors and has re­vealed sev­er­al qual­i­ty con­trol is­sues.

Ac­cord­ing to the FDA’s 483 in­spec­tion re­port, con­duct­ed from Oct.3 to Oct. 14 of this year, the fa­cil­i­ty that was in­spect­ed was a Lupin man­u­fac­tur­ing site in Pune, In­dia, which ac­cord­ing to the com­pa­ny, de­vel­ops biosim­i­lars for the glob­al mar­ket. The 10-page in­spec­tion re­port had a to­tal of 18 ob­ser­va­tions.

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