SNBL USA said it has systemically restructured the operation and re-organized preclinical drug development service capabilities.
In its warning letter, FDA has found nine anamolies. It observed that the Testing Facility Management failed to ensure that personnel clearly understand their functions, and test article mixtures were not appropriately tested for stability, among others.
Seven of the nine items were closed after FDA’s inspections in September 2011 while the report amendments were finalized and submitted in May 2012.
SNBL USA president and COO Dr. Thomas Beck said the firm was confident in its ability to implement the appropriate corrective actions besides improving processes across SNBL’s entire infrastructure.
"We have gone beyond the specific findings to ensure that we fully comply with all applicable statutes and regulatory requirements. I am confident in SNBL USA’s continued diligence in providing the highest quality service in the CRO industry moving forward," Dr. Beck added.
SNL USA is a wholly owned subsidiary of Japan-based Shin Nippon Biomedical Laboratories.