Teva halts production at sterile injectables plant to address FDA concerns

By Eric Palmer Jun 6, 2016 9:49am

Sterile injectable products are notoriously difficult to produce, and the FDA has little tolerance for plant issues that might lead to contamination. Just ask companies like Hospira and Mylan. Now, the FDA has found serious enough problems at a Teva sterile injectables plant in Hungary that it has banned most of its products from the U.S., leading Teva to suspend operations there as it works to get issues resolved.

The FDA recently issued an import alert for all but two products at the facility in Gödöllő: cancer treatment bleomycin and antibiotic amikacin. The alert gives no insight into the nature of the problems, but a translated notice posted Friday by Hungary’s Food and Drug Administration (OGYE) says Teva suspended production four months ago as a precaution following an U.S. FDA inspection at the facility in late January.

Teva Pharmaceutical ($TEVA) in a statement today said that while it is unaware of any adverse reactions reported about products coming out of the facility, it decided to voluntarily stop production at the Gödöllő plant on a temporary basis while it evaluates and responds to the FDA’s concerns.

“We are working around the clock to restart manufacturing operations as soon as possible, and are working cooperatively with regulatory authorities to minimize any potential impact on product availability. We are also identifying alternative sources of supply, where needed. We are very conscious of unnecessarily triggering drug shortages and impacting patients while we focus on resolving regulatory concerns, as patients are always highest priority.”

The notice by the OGYE says the action has taken 200 Hungarian products out of production and the Hungarian agency has asked Teva for weekly updates so that it can avoid shortages, particularly of cancer and morphine drugs. Dr. Csilla Pozsgay, the director general of OGYE, said in the notice that “based on currently available information, products on the market are safe--the FDA primarily objected to the production environment.”

Teva opened the $110 million, 15,000-square-meter (161,458-square-foot) plant in 2012. It said at the time that its 6 production lines were capable of producing between 160 million to 200 million units of injectable meds annually, mostly cancer meds, that were to be sold in 70 countries, primarily in the U.S., Europe and the Far East.

Other companies have been in the situation in which Teva now finds itself. The FDA last year cited three Mylan ($MYL) sterile injectable plants in India in a warning letter for a host of problems. Pfizer's ($PFE) Hospira, which is the largest sterile injectables maker in the world, has had to deal with FDA concerns at several plants in the U.S., India and Italy.

- here’s the FDA import alert
- and the OGYE notice

Teva Pharmaceutical Manufacturing