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Compliance
Compliance
Novo Nordisk’s troubled Indiana site hit with Form 483 following FDA re-inspection
The fill-finish facility in Bloomington, formerly owned by Catalent, was cited for eight observations including persistent contamination and quality systems deficiencies.
June 8, 2026
Compliance
FDA PreCheck pilot draws industry support as questions on execution remain
June 2, 2026
Compliance
Regulatory modernization for cell therapies: Bridging drug GMPs, tissue regulations, and innovation
June 2, 2026
Compliance
FDA announces one-day inspection pilot for low-risk facilities
May 7, 2026
Sponsored
Practical AI in GMP Asset Management: Where Life Sciences Manufacturers Can Drive Value Today
April 15, 2026
Compliance
FDA hits Simtra BioPharma Solutions with warning letter over German site
March 16, 2026
Compliance
Novo Nordisk gets Form 483 from FDA after inspection at Plainsboro, NJ site
March 11, 2026
Compliance
FDA regulatory actions regarding Novo Nordisk site result in CRL for Incyte
March 10, 2026
Compliance
Supreme Court rules against Trump’s ‘reciprocal’ tariffs, pharma not directly impacted
Feb. 20, 2026
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