Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The gener­ics man­u­fac­tur­er Lupin has been giv­en an­oth­er Form 483 from the FDA this year.

US reg­u­la­tors in­spect­ed Lupin’s phar­ma­ceu­ti­cal man­u­fac­tur­ing site in the town of Man­dideep, In­dia from Nov. 14 through Nov. 23, with the 14-page re­port mark­ing 16 ob­ser­va­tions.

The in­spec­tion re­port stat­ed that the site did not have the ap­pro­pri­ate con­trols over its com­put­er sys­tems to en­sure that changes in “mas­ter pro­duc­tion” or records are on­ly done by au­tho­rized per­son­nel, along with writ­ten pro­ce­dures not be­ing es­tab­lished to con­duct an­nu­al re­views of records as­so­ci­at­ed with drug batch­es.

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