FDA 483 - RxCrossroads 3PL LLC - May 09, 2023
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An FDA inspection of RXCrossroads 3PL LLC in Fairdale, KY, identified two significant observations related to quality control and material handling. The firm failed to thoroughly investigate a temperature excursion and properly manage affected drug products, and also failed to appropriately identify the status of drug product lots in storage. These issues indicate deficiencies in the firm's adherence to good manufacturing practices for warehousing and quality control.
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