Aug. 21 at 3:29 PM
$LLY $NOV Novo Nordisk’s Bloomington, Indiana fill-finish facility (legal name: Catalent Indiana LLC; FEI 3005949964) received a 15-page Form FDA 483 following the April 13–24, 2026 reinspection.
FDA documented recurring mammalian-hair contamination in sterile products, repeated roof leaks/water intrusion, foreign particles, delayed or inadequate investigations, and weaknesses in aseptic-process controls. The reinspection was later classified OAI — Official Action Indicated.
Official FDA Form 483:
https://www.fda.gov/media/193455/download
OAI report:
https://www.pharmamanufacturing.com/compliance/article/55396759/fda-classifies-re-inspection-of-novo-nordisks-indiana-site-as-official-action-indicated
