FDA warns Teva over violations at China plant
- Israeli generics giant Teva disclosed Thursday it had received a warning letter from the Food and Drug Administration over manufacturing violations at an active pharmaceutical ingredient facility in China, which were first identified in a September 2016 inspection.
- The FDA flagged concerns with manufacturing control and sampling processes, Teva said in a regulatory filing with the Securities and Exchange Commission.
- In its notice to the SEC, Teva said it is already taking corrective action to fix the issues cited by the FDA and plans to respond to the warning letter by May 1.
While the drugmaker offered no other details on the severity of the violations, the warning letter adds to Teva's compliance headaches.
Last October, another Teva manufacturing facility in Hungary had been hit with a warning letter, after an earlier inspection had found a range of deficiencies in the site's laboratory and monitoring practices.
According to the drugmaker's website, Teva has an API production plant located outside the city of Hangzhou, in addition to one run by its stand-alone subsidiary TAPI International, also in Hangzhou.
Elsewhere, Teva has its hands full.
While the company paid about $520 million to resolve criminal charges over an international bribery scheme last year, Teva has also been named in a sweeping federal lawsuit investigating price-fixing for generic drugs.
Add in looming competition to the top-selling drug Copaxone (glatiramer), a broad corporate restructuring, and the latest CEO change, Teva has a challenging to-do list.
Shares in the company have fallen steadily since last fall, and is now trading at about $32 per share, down from a 52-week high of $58.16.
- Teva Form 6-K
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