The FDA sent 40 per cent more GMP warning letters to biopharma facilities outside the US in fiscal 2011 than the previous year.
In the last fiscal year, ended March 31, the US Food and Drug Administration (FDA) sent warning letters relating to drug manufacturing and quality to 52 facilities, more than half of which targeted overseas plants.
A 40 per cent year-on-year increase in overseas warning letters continued the trend seen since 2008, when the FDA sent five manufacturing warning letters to sites outside the US, close to half of which went to Ranbaxy. Since then the FDA has sent more each year, starting with the 19 it issued in 2009.
The data, gathered by in-PharmaTechnologist from FDA records, suggests efforts to boost oversight of overseas production plants, such as opening overseas offices, are leading to more warning letters.
In the past two years the FDA has sent 15 quality-related warning letters to companies in China and India, more than twice as many as it sent in the two preceding years. FDA offices in China and India opened around the start of 2009.
An upwards trend is also seen in the number of warning letters going to production sites in Western Europe and Latin America. The upturn is likely a combination of increased overseas oversight and a newfound willingness to send warning letters.
Speaking after receiving a warning letter in January, Lonza said in years gone by its violations would likely have gone unpunished. However, as Hospira and others have also said, it now faces a new FDA.
“We have to face the fact that the regulatory authorities have raised the bar significantly. We have to adapt to that and we have to raise our regulatory standards accordingly. This will obviously cost money [and] take some time”, Stephan Kutzer, head of custom manufacturing at Lonza, said.