483
Medco ManufacturingMedco Manufacturing – FDA 483, Apr 9, 2026
Record Details
An FDA inspection of Medco Manufacturing, LLC in Spring, TX, a manufacturer, specification developer, and repackager/relabeler, revealed deficiencies in their risk management processes. The firm failed to adequately document risk assessments, specifically regarding the hazard of excessive (b)(4) and the appropriate severity rating for contamination risks. These issues indicate a significant concern with the firm's ability to identify and assess potential patient harm.
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ID · 03941b6c-6017-4b1a-bc1a-46887c9bc534
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