Chinese pharmaceutical manufacturer receives import alert from US FDA

A Chinese company, Beijing Shunxin Meihua Bio-technical Co., received an import alert by FDA on 22 July 2014. FDA's import alert was for refusing inspection and the other for failing to operate according to good manufacturing practices. In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) gave FDA authority under Section 709 to ban a company's products if it delayed, denied or limited an inspection of a facility.

A year later, the agency released a guidance document on the subject, defining what it meant by those terms, and establishing under what terms a company might find its products banned from US markets. The company was last inspected by FDA in February 2014. As a result, the company cannot deliver any of its products to the US market.

A Chinese company also got a Warning Letter in September 2012 after it had thrown three FDA inspectors out of the facility after they began revealing some serious deficiencies. Some firms sought to refuse or delay entry of FDA inspectors into their facility, hoping that the additional time could be used to either clean up a facility, delete certain records or for covering up deficiencies.