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The firm’s own SOP states that OOS results must be immediately reported to Quality and the pharmacist-in-charge, and that investigation, root cause analysis, recall, and customer notification procedures “shall be followed when applicable.” The FDA pointedly notes that the “when applicable” language effectively makes investigation and notification optional rather than mandatory

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Gastrointestinal Health: Supports the healing of gastrointestinal issues, including ulcers, inflammatory bowel disease (IBD), and other conditions that compromise the integrity of the digestive tract