SNBL – the US subsidiary of Japanese CRO Shin Nippon Biomedical Laboratories – was issued with an US Food and Drug Administration (FDA) warning letter in August 2010 after the agency detected problems at the firm’s laboratory in Everett, Washington.
Among other things the FDA raised questions about: staff training; SNBL’s efforts to comply with good laboratory practices (GLP); and its implementation of SOPs.
In a statement issued earlier this month SNBL said it has completely resolved seven of the nine observations detailed by the FDA and is working to fix the remaining shortcomings – both of which requirement amendments to past studies the CRO has worked on.
Company president Thomas Beck said resolution of the problems was a due to fundamental changes implemented at SNBL since 2011,
“We are pleased the recent FDA response reflects the systemic changes and process improvements we have made over the past year.”
He cited changes to the firm’s management, new staff with expertise in pathology, safety assessment and toxicology as well as enhanced training and monitoring as the key factors.
SNBL also plans to implement the Provantis toxicology data base system according to Beck, who predicted it would “increase the quality of our reporting and shorten the timeline to finalize studies."
Macaque shipment blocked
Other recent news for SNBL has been less positive, with the Israeli Courts blocking a shipment of animals due to be sent to the firm – partly as a result of press ure from animal rights groups.
Late last month Israeli attorney general Yehuda Weinstein stopped the export of a group of female macaques due to be sent to SNBL in the US, arguing that because 70 of the animals had been caught in the wild it is illegal to ship them for research purposes.
The comment – reported in the Jerusalem Post – was a response a petition that animal rights group ‘Let the Animals Live’ filed with the High Court requesting that an earlier decision allowing breeder Mazor Farm to make the shipment be overturned.
SNBL declined to comment on the decision when contacted by Outsourcing-pharma.com.