483
OrBion Pharmaceuticals Private LimitedFDA 483 - OrBion Pharmaceuticals Private Limited - September 08, 2023
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During an inspection, Orbion Pharmaceuticals Private Limited in Sriperumbudur, India, was cited for three significant observations. These included failures in establishing adequate production and process controls, issues with equipment design and use, and non-adherence to established laboratory control mechanisms. The findings indicate deficiencies in ensuring drug product quality and manufacturing integrity.
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ID · b5f7d05a-7dad-40db-95aa-7bec1c6cb422