HSP

The Food and Drug Administration said it found "significant" manufacturing violations at a 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 an FDA inspection of an Irvine, Calif. facility last July.

Propofol, an injectable drug, is one of the most widely used medicines for general anesthesia or sedation in operating rooms and intensive care units. Teva recalled some of the product last year after elevated levels of toxins were discovered.

Denise Bradley, a Teva spokeswoman, said the company responded to the warning letter and continues "to work with the FDA to address all concerns." She said the company currently isn't making propofol.

The FDA's inspection coincided with the recall of propofol. Teva recalled 57,000 vials of propofol after elevated levels of toxins were found in some lots. At the time, the FDA said more than 40 patients who were taking the drug experienced post-operation fever, chills and other flu-like symptoms.

In the warning letter, the FDA said Teva didn't test each lot of raw materials that were used to make propofol "to determine the presence and levels of bacterial endotoxin."

The FDA also said the company detected an "out-of-trend level" of bacterial endotoxin contamination in three vials propofol but couldn't determine the cause of the contamination. The FDA said the lot was released but later recalled.

Manufacturing problems at Teva as well as Hospira Inc., (HSP) which also makes propofol, have contributed to a shortage of the widely-used drug. Hospira received an FDA warning letter dated April 12 involving manufacturing facilities that make propofol and other products.

To cope with the shortage FDA has allowed APP Pharmaceuticals, Inc., a subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (APCVZ) to import a similar drug, Propoven, into the U.S. Propoven is not FDA approved but is used in several other countries.

An overdose of propofol was ruled as the cause of singer Michael Jackson's death last June. Teva has said the recalled batches of propofol weren't the ones involved in Jackson's death.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

(Alicia Mundy contributed to this article.)

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