Manufacturing Compliance Updates In Brief From US FDA And EU

10 May 2018

• By Joanne S. Eglovitch

Many of the six drug GMP warning letters the US FDA has issued since late March targeted lax testing practices, particularly at OTC firms abroad. Two EU GMP non-compliance notices highlighted data integrity shortcomings in India. FDA also posted a couple of Form 483 reports and added four facilities to its GMP import alert.

FDA sent a warning letter on April 19 to API maker Lijiang Yinghu Biochemical and Pharmaceutical Co. in Lijiang, a city in China's Yunnan Province, for their lax approach to computer access and for missing laboratory records.

For example, the laboratory equipment such as the high-performance chromatography (HPLC) and gas chromatography (GC) systems used to generate analytical...