Compliance

FDA classifies re-inspection of Novo Nordisk’s Indiana site as Official Action Indicated

In response, Scholar Rock will remove the Bloomington fill-finish facility from its Biologics License Application with the agency and rely on a third-party provider.

Aug. 10, 2026

Compliance

FDA classifies re-inspection of Novo Nordisk’s Indiana site as Official Action Indicated

Cellares sees FDA’s PreCheck pilot as catalyst for cell therapy manufacturing

FDA picks seven companies for PreCheck pilot program including two CDMOs

Novo Nordisk’s troubled Indiana site hit with Form 483 following FDA re-inspection

FDA PreCheck pilot draws industry support as questions on execution remain

Regulatory modernization for cell therapies: Bridging drug GMPs, tissue regulations, and innovation

FDA announces one-day inspection pilot for low-risk facilities

Practical AI in GMP Asset Management: Where Life Sciences Manufacturers Can Drive Value Today

FDA hits Simtra BioPharma Solutions with warning letter over German site

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