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In its recommended follow-up, the agency notes: “You do not provide a retrospective review to ensure that you have fully identified and thoroughly investigated all OOS results and discrepancies.” 8 This regulation has been one of the most frequently cited violations for many years, demonstrating that industry continues to struggle with implementing effective investigations

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If you are unable to get the correct amount of water transferred, contact your prescribing provider, who can determine whether any adjustment to your prescription is appropriate