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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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From a chemical compatibility perspective, adding bacteriostatic water to a third-party peptide can produce unpredictable results if the peptide material has an unsuitable pH, contains residues from manufacture, has degraded during storage, or has poor solubility characteristics