Regulatory News

FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected

The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators.

The company, Beijing Shunxin Meihua Bio-technical Co., was placed on import alert by FDA on 22 July 2014. FDA's import alerts—one for refusing inspection, and the other for failing to operate according to good manufacturing practices—indicate that the firm "refused FDA inspection"—a big problem that the agency is now uniquely able to deal with.

New Authority

In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) gave FDA authority under Section 709 of the law 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.

In the past, some firms have sought to refuse or delay entry of FDA inspectors into their facility, hoping the additional time could be used to either clean up a facility or expunge certain records. In September 2012, for example, FDA released a Warning Letter to a Chinese company that reportedly threw FDA inspectors out of the manufacturing facility after they began uncovering a host of serious deficiencies.

The new rules were intended to prevent a company from stalling for time or covering up blatant deficiencies. The thinking is that any company that prevented FDA from access to a facility would be trying to hide something serious from the regulator.

Questions Remain

It isn't clear from FDA's import alert what, specifically, caused the agency to ban Beijing Shunxin Meihua Bio-technical's products from entering the US. While the language implies that no FDA inspectors were permitted into the facility, lesser infractions might also have resulted in the same language under FDA's understanding of FDASIA Section 709.

The company was last inspected by FDA in February 2014, according to FDA data available on FDAzilla.