FDA hands India’s Natco Pharma another 483, with eight observations cited 

In­di­an man­u­fac­tur­er Nat­co Phar­ma has been hit with an­oth­er 483, fol­low­ing an FDA in­spec­tion made at its phar­ma man­u­fac­tur­ing fa­cil­i­ty, lo­cat­ed at 509 228 Telan­gana, In­dia, be­tween Oct. 9 and Oct. 18 this year.

The 26-page in­spec­tion re­port was is­sued to the man­u­fac­tur­er on Oct. 18 and was pub­lished on Wednes­day, out­lin­ing eight ob­ser­va­tions.

Equip­ment was not prop­er­ly as­signed to the cor­rect per­son­nel and was op­er­at­ed by unau­tho­rized em­ploy­ees, in­clud­ing equip­ment used to man­u­fac­ture batch­es of prod­ucts for the US mar­ket, the Form 483 said.

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