GMP News: Chinese Company Refuses GMP Inspection and Gets an Import Alert from the FDA

The US FDA has placed the Chinese company Beijing Shunxin Meihua Bio-technical Co on an import alert. Consequently, the company cannot deliver any product to the US market. According to the information portal Regulatory Focus, the import alert was published on 22 July 2014. Last year, the FDA referred to its competence in a Guideline and emphasised the fact that any refusal or obstruction to an inspection would have immediate consequences. You can read more on the topic in our GMP News "Denying, Delaying, And Refusing: How to Fail a FDA Inspection". Already in the past, a Chinese company got a Warning Letter after it had thrown three FDA inspectors out of the facility.

GMP News: Chinese Company Refuses GMP Inspection and Gets an Import Alert from the FDA