• Safi Bello

Teva China API plant smacked by FDA warning letter, adding to drugmaker's burdens

Fierce Pharma ------- The FDA has nailed another Teva manufacturing facility with a warning letter, this one for an API facility in China. The Israel-based drugmaker in a short SEC filing said the letter had been issued April 10, following an inspection of the facility in September that found issues with the plant’s manufacturing control and sampling processes. Teva said it is already taking steps to deal with the FDA concerns “as well as the underlying causes of those concerns.” It said it will provide the FDA a full response by May 1. To learn more click on the picture below to read the article.

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