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CAPA Plan Expectations and Regulatory Recommendations Based on the cited violations, the FDA requires Catalent to implement comprehensive remediation supported by an independent assessment, with a clear distinction between immediate causal factors and underlying root causes

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Traditional methods of mixing two separate lyophilised powders (Cagrilintide and Tirzepatide) introduce significant risks of dosing error and contamination

Of these, 44 had AIH, 25 had PBC, 32 had PSC, and 632 had non-AILD etiologies

Erasmus, J