XGene Sterile Products CMC Intelligence™

Catalent Indiana LLC FDA 483: 8 Observations at Bloomington, Indiana and the Aseptic/Sterile Manufacturing Pattern Every Sterile Injectable Quality Leader Should Assess

An eight-observation FDA Form 483 at Catalent Indiana’s Bloomington sterile injectable facility documents that a mammalian-hair contamination issue underlying a November 2025 Warning Letter has continued into 2026.

Catalent Indiana LLC FDA 483: 8 Observations at Bloomington, Indiana and the Aseptic/Sterile Manufacturing Pattern Every Sterile Injectable Quality Leader Should Assess Read More »

CareFusion 213, LLC (BD) Class I Recall — ChloraPrep Sterile Antiseptic Applicators: The Sterile Manufacturing System Failure Behind the Recall and What Every Aseptic Processing Director Must Address

A Class I recall of BD ChloraPrep sterile antiseptic applicators for non-sterility and a packaging-seal defect follows an April 2026 Warning Letter at the same El Paso, TX facility citing the identical failure pair.

CareFusion 213, LLC (BD) Class I Recall — ChloraPrep Sterile Antiseptic Applicators: The Sterile Manufacturing System Failure Behind the Recall and What Every Aseptic Processing Director Must Address Read More »