The agency sent a letter to the Israeli drugmaker, because its Parenteral Medicines unit failed to correct several manufacturing issues at its Irvine, California, facility, which resulted in contaminated batches of an injectable anesthetic called Propofol, which is widely used in operating rooms and intensive care units. Propofol was last in the news in a big way when it was discovered that Michael Jackson (you know, the former king of pop) died of an overdose of the med (see here).
Teva recalled thousands of vials last year after elevated levels of toxins were discovered. At the time, the FDA said more than 40 patients suffered fever after operations, chills and flu-like symptoms. The December 2009 letter, which was posted today on the FDA site, noted that Teva responded six times to the agency's July 2009 inspection, but each lacked "sufficient corrective actions." At one point, in fact, contamination was found in three finished vials, but "no corrective action was taken in response to this finding at the time of manufacture, and your firm released the lot," the FDA said in the letter.
Teva isn't the only one having trouble making this anesthetic. Hospira also received a warning letter recently about manufacturing problems, which have contributed to a shortage of propofol.