“On 28 March 2013, AstraZeneca received a subpoena duces tecum from the US Attorney’s Office in Boston, Massachusetts seeking documents and records related to manufacturing, quality or good manufacturing practices at our Macclesfield facility in the UK. We are confident in the quality of our manufacturing processes and will be cooperating with the inquiry,” Ayesha Bharmal, a spokeswoman for AstraZeneca told us.
The request for more information regarding its manufacturing practices comes as the Macclesfield facility is likely to see staff expansions as the company looks to reorganize its R&D divisions. Currently home to 2,500 staffers, the site has a history of cuts and re-structuring. In 2007, the facility saw the loss of 700 jobs, representing over a quarter of its workforce there.
“Macclesfield is AstraZeneca’s second largest manufacturing site and our European centre for packaging. It is home to the production line for Zoladex and tablet formulation for medicines including Seroquel IR and XR, Zestril, Accolate and Iressa also take place at the site,” Bharmal said.
AstraZeneca has a rocky relationship with US DOJ (Department of Justice). In 2010 the company entered into a US Corporate Integrity Agreement for illegal marketing practices of Seroquel and the DOJ fined AstraZeneca $520mn.
Rare Occurrence
It’s rare for a US Attorney’s Office to seek information on manufacturing practices from an overseas manufacturing facility unless it’s related to a consent decree, as typically the FDA conducts inspections of such facilities.
At the request of the FDA in January 2012, the DOJ’s District Court in Maryland filed a consent decree against Ranbaxy for numerous problems related to its manufacturing and testing at its India plant.