FDA warns Teva over California plant
pharmafile | April 30, 2010 | News story | Manufacturing and Production | Teva, manufacturing compliance
Teva has become the latest drugmaker to be rebuked by the FDA for not responding effectively enough to compliance problems uncovered during an inspection at a manufacturing plant.
The Israeli company – the largest generic drugmaker in the world – has been sent a warning letter by the US regulator for failing to resolve Good Manufacturing Practice (GMP) problems uncovered by an agency inspection of its facility in Irvine, California, last July.
Teva filed responses to the agency’s concerns on six separate occasions between August and November 2009, but was unable to convince the FDA that it had put its house in order.
The compliance problems related to the bacterial contamination issues arising during the production of propofol, a short-acting anaesthetic product. More than 57,000 vials of the product were recalled after the US Centers for Disease Control and Prevention (CDC) issued a health advisory in July 2009 warning physicians not to use certain lots of the product.
The CDC said at the time that some patients treated with the anaesthetic, particularly those undergoing endoscopy procedures, subsequently developed febrile reactions to the drug and on testing were found to have elevated levels of endotoxin, suggestive of a bacterial infection.
The FDA letter raises issues with the processes Teva used for testing bacterial contamination, but also notes that Teva actually found that three vials of its propofol product were contaminated, but still allowed the batch to be released onto the market. The lot from which the vials came was subsequently part of the recall.
Teva says that it no longer makes propofol, but has agreed to temporarily close down production at the plant while it works on a solution to the problems.
Meanwhile, Teva’s exit from the propofol market, coupled with contamination problems at another key US supplier Hospira, has led to shortages of the anaesthetic.
As an interim measure the FDA has granted APP Pharmaceuticals, a temporary license to import another propofol product, Fresenius’ Propoven, to alleviate the shortage. APP also distributes other versions of the anaesthetic in the US, including the original AstraZeneca brand Diprivan and APP Propofol.
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