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Most concerns in study quality were due to potential risks of confounding

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Sterile Manufacturing Faces Even Greater Scrutiny Because the facility manufactures sterile injectable products, FDA also cited significant aseptic processing deficiencies, including: Inadequate airflow demonstrated during smoke studies

The patients Ive seen do this consistently end up having to do the foundational work anyway, a decade later, on a body that spent ten years compensating for something that should have been addressed directly

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