The Food and Drug Administration said it found "significant" manufacturing violations at Teva Pharmaceutical Industries Ltd. (TEVA) facility that makes the sedative drug propofol.
The agency posted a Dec. 11 warning letter to its Web site on Tuesday. The letter involved violations found during a FDA inspection of an Irvine, Calif. facility last July. Propofol, an injectable drug, is used for general anesthesia or sedation in operating rooms and intensive care units.
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