Since 2013 the FDA has allowed eight plants whose products are otherwise banned from the US to go ahead and import some drugs or ingredients to avoid shortages, according to FDA Import Alert records.
Reported on www.wessexlifescience.co.uk, because of the nature of the business, with companies in China or India often being a primary source of essential drugs, the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record.
The exclusions in questions have included six plants in India, with one operated by Canada’s Apotex and one by Wockhardt, an Indian company that has run into a number of FDA citations. The exempted facilities also include a Teva ($TEVA) plant in Hungary and a plant operated by China’s Zhejiang Hisun Pharmaceutical.
The drugmakers have all indicated they take quality seriously and are working closely with the FDA to resolve their issues.
Read the full story about the FDA’s decisions.
