GMP News - Inspections/Audits

EU GMP Inspectors from the competent authority in Romania identified several GMP deviations during a GMP inspection at a Chinese API manufacturer. As a consequence, a GMP Non-Compliance Report has been issued. Read more here about the GMP Non-Compliance Report.

The US FDA has placed the Chinese company Beijing Shunxin Meihua Bio-technical Co on an import alert. Read more here about the FDA Import Alert.

On 7 July 2014 the US FDA has issued a Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co., Ltd. located in Taizhou, Zhejiang Province in China. The company is a producer of APIs and failed to establish basic GMP principles. Please read more about the FDA Warning Letter.

On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year. Read more about this Warning Letter here

The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility. Read more about the FDA Warning Letter.

GMP Compliance problems found at more and more manufacturers in India are a major concern of EU and FDA regulators. Again the FDA has issued an Import Alert for an Indian Manufacturer. Please read more.

According to the current Budget Request, FDA would like to perform approx. 20 percent more foreign GMP inspections. Read more.