Almost two years after receiving an FDA warning letter citing 9 violations at its Everett, WA, laboratory, SNBL USA announced that it remedied 7 of them. But while the U.S. subsidiary of Japanese CRO Shin Nippon Biomedical Laboratories is resolving its issues in one part of the world, it is caught up in an animal rights scandal in another.
Since receiving the FDA warning letter in August 2010, SNBL made numerous changes to the lab--the CRO tweaked its staff, provided additional training for all of its employees and enhanced programs to monitor equipment maintenance and calibration, according to a company release. And comply with the two remaining violations, SNBL will need to finalize several report amendments regarding specific assay issues on certain past studies, something it has already made "significant progress" on, it says. (The FDA's warning letter to SNBL, complete with a breakdown of the violations, can be found here.)
But as it corrects its mistakes stateside, SNBL is entangled in another controversy, this time in Israel. This month, the country's attorney general, Yehuda Weinstein, stopped a shipment of almost 100 macaque monkeys to SNBL in the U.S. He argued that the particular animals in this case didn't conform to national law when it comes to exporting creatures for medical purposes, according to The Jerusalem Post. Though SNBL declined to comment about the issue to Outsourcing-Pharma, it has made an investment to improve animal living conditions at the Everett lab, as the publication also reports.
- read the release from SNBL
- learn more from Outsourcing-Pharma
- here's additional info from The Jerusalem Post