European regulators sanction Chinese company for plant flaws

Authorities in Europe have flagged a noncompliant China plant for 18 shortcomings revealed in a recent inspection, the latest in a series of crackdowns by Western regulators working to ensure the quality of drugs coming from Asian plants.

Inspectors with France's drug regulator noted the deficiencies during a May 2015 examination of a plant in the Paojiang Industrial Zone owned by Shaoxing Pharmaceutical. The European Medicines Agency (EMA) recently posted the notice to its website.

Notably, two critical offenses listed were that the company allegedly falsified the source of its API, thiamphenicol, and released product without traceability of testing measures. According to a notice in EudraGMDP, staff at the plant stored hoses for unloading solvent on a dirty floor in an area of the facility not included in the layout. Another "major" offense was a lack of a set procedure to determine if data were manipulated.

Officials recommended a recall of affected products and issued the site a noncompliance notice, disqualifying it from being listed on marketing authorization applications. The EMA shares the info with all of the countries in the European Union, so any of them can stop imports.

The move follows a similar crackdown last summer when Italian regulators recommended bans for two plants in China and one in India for related issues, including the potential for data falsification. The Italian officials said uncontrolled storage areas, the possibility of contamination and substandard document storage were among the dozens of issues at the three plants.

In recent years, U.S. and European regulators have worked to correct manufacturing practices at plants in China and India and assure that the drugs coming from there are quality products. However, staffing problems at the FDA have hampered U.S. efforts, with Bloomberg recently reporting that there are only two FDA inspectors for more than 700 plants in China. The news service added that more than 80% of main APIs for the world's drugs are manufactured in the countries.

It's not only local companies receiving the enforcement action in China, as last year plants there owned by GlaxoSmithKline ($GSK) and Pfizer ($PFE) were cited by the U.K. and the U.S., respectively.

- here's the EudraGMDP site

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