483
Alcami Carolinas CorporationAlcami Carolinas Corporation – FDA 483, Apr 5, 2024
Record Details
An FDA inspection of Alcami Carolinas Corporation, a sterile drug manufacturer in Charleston, SC, revealed a significant issue within its laboratory control system. The firm failed to follow established specifications and test procedures, leading to analyst errors during testing runs for a Sodium Chloride Diluent batch. These errors resulted in an out-of-specification value, indicating a breakdown in adherence to training and procedural guidelines.
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ID · 9d9b8e36-2052-409e-8d46-494727866ac8
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