QC vi­o­la­tions raised by FDA at an­oth­er Au­robindo site

Gener­ic drug man­u­fac­tur­er Au­robindo Phar­ma has re­ceived an­oth­er 483 in­spec­tion re­port from the FDA, this time with qual­i­ty con­cerns, par­tic­u­lar­ly in re­sponse to cus­tomer com­plaints.

The 17-page re­port gives the de­tails of an in­spec­tion con­duct­ed by the FDA at Au­robindo’s ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) man­u­fac­tur­ing fa­cil­i­ty in Hath­noo­ra, In­dia, with a to­tal of 10 ob­ser­va­tions be­ing not­ed by the US reg­u­la­tor.

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