Quality problems lead to short-term layoffs at Baxter Ireland
pharmafile | February 22, 2011 | News story | Manufacturing and Production |Â Â Dianeal, Extraneal, Ireland, Nutrineal, baxter, job cuts, manufacturing compliance, peritoneal dialysisÂ
A contaminated production line at a facility in Ireland operated by Baxter Healthcare has resulted in 150 staff being laid off for four months, according to local press reports.
Around 10% of the total workforce at Baxter’s plant in Castlebar has had duties suspended thanks to the discovery of endotoxin contamination in peritoneal dialysis products manufactured at the unit. The company has been transferring production of the affected products to other sites in its manufacturing network while it tries to identify the root cause of the problem.
Baxter management said on a conference call earlier this year that the ongoing problems at Castlebar had cost around $30 million, and that the situation was expected to take “several months” to resolve. The company intends to dismantle and re-assemble the production line in an attempt to remedy the contamination issue.
The company has been in consultation with the EMA over the incident, and the European regulator’s Committee for Medicine Products for Human Use (CHMP) has initiated a review of the manufacturing site.
Peritoneal dialysis products affected by the contamination issue include Dianeal, Extraneal and Nutrineal. While potentially serious adverse reactions could occur as a result of endotoxin exposure, the CHMP said last month that a recall was not possible because there were no replacements for the “life-saving treatments”.
News of the layoffs comes as another blow to the local population, given that Baxter has already announced 200 jobs at the Castlebar plant would go during 2011, mainly from voluntary redundancies and non-renewal of temporary contracts.
Meanwhile, news of the temporary layoffs in Ireland comes on the back of two warning letters sent to Baxter by the US FDA concerning two facilities in Puerto Rico.
The two plants – in Guayama and Jayuya – were inspected by the FDA last year and found to have a number of GMP-related violations. Products cited by the letters include several amino acid preparations, critical care medicines and Suprane (desflurane), an anaesthetic.
Phil Taylor
Related Content
Baxter expands US portfolio with new injectables
Baxter International has announced the continued expansion of its pharmaceuticals portfolio with the launch of …
Astellas plans to invest over €330m in new facility in Ireland
Astellas Pharma has announced that it is preparing to submit a planning application to build …
Takeda poised to cut sales jobs in Japan as restructuring continues
Japan’s biggest drug firm Takeda is said to be mulling plans to cut back its …
