he latest broken link in the pharmaceutical supply chain has appeared in Hungary, where Teva Pharmaceuticals has suspended production at a plant following a crackdown by the US Food and Drug Administration.
The drug maker voluntarily halted work at its Godollo facility, which makes sterile injectable medicines, as “a precautionary measure” shortly after FDA inspectors visited last January, a Teva spokeswoman told us. The company is “working around the clock to restart manufacturing operations as soon as possible,” but she did not provide a timeline for when production may resume.
The shutdown only came to light after Hungarian regulators late last week issued a notice in an attempt to address concerns about drug shortages. Teva makes about 200 products at the facility, which is located outside of Budapest and can reportedly produce up to 200 million units of injectable drugs annually. The company invested about $110 million in the plant, which opened nearly four years ago.
The disclosure by Hungary’s National Institute of Pharmacy, or OGYEI, came several days after the FDA also issued a so-called import alert, which is a notice about products that are banned from entering the United States. The FDA alert cites issues with good manufacturing practices, a regulatory term for minimum standards, but specific problems were not disclosed.
A source familiar with the situation confirmed that following the January inspection, the FDA had issued a so-called 483 form, which identifies manufacturing problems that may constitute violations of the US Food, Drug, and Cosmetic Act. The Teva spokeswoman and the FDA spokesman, however, would not comment.
The Teva spokeswoman did say the company is attempting to shift production to other plants, and added that the company is “not aware” of adverse events associated with products at the plant, which ships to various countries. The FDA spokesman told us that adverse event reports filed with the agency would have to be researched and a response would not be available immediately.
For now, there is nothing to suggest the disruption will notably alter Teva’s fortunes. The company has dozens of manufacturing sites around the world and, while the Hungarian site supplies medicines for the US, Europe, and Asia, the company is able to shift some production among facilities. The Hungarian plant makes about a half-dozen products for the US market.
On a broader scale, however, the episode underscores the ongoing challenges that even the largest drug makers face in maintaining their plants. Over the past several years, most of the production infractions cited by the FDA have involved smaller players — often, generic drug companies in India — as the agency seeks to ensure the veracity of the pharmaceutical supply chain.
Nonetheless, this development is a reminder that such concerns extend to any number of operations. This is especially true for facilities that make injectable and infused medicines, given concerns over contamination.