FDA Conducts Surprise Israel Inspection at Teva Plant

Teva, world’s largest generic drugmaker, says checkup related to request for approval of generic drug

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Workers inside a Teva production plant.
A Teva production plant. Credit: Nir Kafri

Officials from the U.S. Food and Drug Administration conducted a surprise inspection of Teva Pharmaceutical Industries’ tablet production plant in the Tel Aviv suburb of Kfar Sava on Sunday. The visit is related to a Teva request for FDA approval of a generic drug.

Teva issued a statement Sunday saying: “The inspection is a routine inspection to examine generic product files that have been submitted for FDA approval. Inspections of this kind are conducted at every FDA-approved plant from time to time, including the Kfar Sava site.”

Over the past several years, the Israeli company, the world’s largest generic drugmaker, has faced a number of quality control issues that have eaten into its revenues and profits. One such case led to a decision by the company last week to close an injectable product plant in Godollo, Hungary, resulting in the layoffs of 500 employees. The decision followed an inspection of the facility in January 2016 that found deficiencies in production, laboratory oversight and the quality of the documentation of the production process there.

In May 2016, the FDA barred the import into the United States of nearly all of the items produced at the Hungarian plant, a move that was followed in October by an FDA warning letter to Teva regarding the lapses found in the inspection. As a result, Teva decided to voluntarily halt production and transfer the product lines there to other company facilities.

The Godollo factory was opened in 2012 with an investment of $110 million. The failure of the undertaking prompted Teva to make an $80 million accounting provision for a decline in the value of its investment there.

The FDA also found deficiencies last year at a Teva plant in Hangzhou, China that produces active ingredients for drugs. The company is currently working to address the deficiencies. An inspection at Teva’s Mexican subsidiary, Rimsa, also led to a halt to production at a plant in Guadalajara. Teva bought the Rimsa plant last year in a $2.3 billion deal, only to shut it down immediately, saying the operation was overrun by improprieties. Rimsa’s previous owners, the Espinosa family, denied this, and the two sides became locked in a legal battle.

With reporting by Reuters.

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