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636 Hematologic function must be frequently and carefully monitored during and after pentostatin therapy, particularly during the first several courses of therapy in patients at increased risk of myelosuppression (eg, those with hairy cell leukemia)

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When FDA investigators informed the firm that process validation had not been conducted prior to product distribution (which is a foundational cGMP requirement under 21 CFR 211.100), the company responded that it had been unaware of the legal obligation because its AI agent had never flagged it as a requirement