The FDA issued a warning letter to Novo Nordisk over manufacturing problems at a Bloomington, Indiana factory it acquired from Catalent, asking the drugmaker to analyze all sites purchased in the deal. The agency’s letter cited quality concerns and requested corrective actions and a company‑wide assessment of acquired facilities. Novo Nordisk must respond with remediation plans and timelines; the letter raises questions about integration and oversight after M&A in biologics manufacturing. The agency’s action could affect supply planning for key products and underscores regulator focus on post‑acquisition quality governance.