FDA 483 - A2A INTEGRATED LOGISTIC INC - February 24, 2025
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A2A INTEGRATED LOGISTIC INC in Fayetteville, NC, a wholesale distributor, was cited for significant deficiencies related to the Drug Supply Chain Security Act (DSCSA) and proper drug storage. The inspection revealed failures in establishing adequate systems for suspect/illegitimate product handling, maintaining transaction information, and working with authorized trading partners. Additionally, the firm lacked proper calibration and temperature monitoring for drug storage, leading to a vaccine being stored at an incorrect temperature.
ID · 09f8ac48-8dad-4a43-9434-a02c27de0b99