Home > Newsletters > The QMN Weekly Bulletin > Citra Labs’ Rejection Limits Too Wimpy, Form 483 States
The QMN Weekly Bulletin
June 29, 2012 | Vol. 4 No. 26
Citra Labs’ Rejection Limits Too Wimpy, Form 483 States
Citra Labs, a maker of injectable anticoagulants, received a lengthy, 28-observation Form 483 noting various visual inspection shortfalls, including a lack of a rejection limit for glass particles. After finding glass shards in filled vials of anticoagulant citrate dextrose solution, Citra Labs neither determined the source nor took timely or effective corrective and preventive action to reduce or eliminate the glass from filled vials of the biologic drug, the Dec. 9, 2011, form states.
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