483
MindSight Medical LLCFDA 483 - MindSight Medical LLC - May 05, 2025
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Record Details
MindSight Medical LLC in Dallas, TX, a human tissue distributor, was cited for two observations during an FDA inspection. The firm failed to establish acceptable temperature limits for storing HCT/Ps according to manufacturer specifications and lacked defined temperature ranges for frozen HCT/Ps. Additionally, the firm's Standard Operating Procedures did not define corrective actions for temperature excursions during HCT/P storage.
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- Dallas District Office
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ID · 7716aaa7-4631-4ed6-a7df-f0d8bd3f22e8