NEW YORK (AP) – Federal regulators say Teva Pharmaceutical Industries Ltd.’s Parenteral Medicines unit failed to correct manufacturing problems at its Irvine, Calif. facility that caused contamination in batches of an anesthetic.
The Food and Drug Administration sent the Israeli generic drug developer a warning letter in December citing contamination with batches of pharmaceuticals made at the facility. The letter was posted on the agency’s Web site.
Teva said it continues to work with the FDA to address any concerns.
The FDA warned the company over a failure to correct issues with bacterial endotoxin contamination found in vials of propofol injectable emulsion, which is used as a general anesthesia. The lot was recalled.
“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.
There were several other violations focusing on manufacturing the drug and contamination issues. Other violations observed during an inspection included a failure to subject lots to microbiological tests. The agency said the company failed to test each lot of raw materials used to make propofol injectable emulsion to determine the levels of bacterial contamination.
The agency also warned the company about a failure to clean and sanitize equipment and utensils at appropriate intervals to prevent contamination.
The FDA said the company “should take prompt action to correct the violations” and a failure to comply could result in legal action.
Teva said it has responded to the warning letter and moved its yearly plant shutdown to the last week in April from December “in order to more efficiently address process enhancements at the facility.”
Date: April 27, 2010
Source: Associated Press
Filed Under: Drug Discovery