SNBL USA Ltd., a wholly owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd., announced it has received a formal close out letter from the U.S. Food and Drug Administration (FDA) indicating that it has successfully resolved all the issues identified in an August 10, 2010, warning letter.
SNBL USA, with support from the SNBL Group, has systemically rebuilt the operation and re-established its ability to provide expertise, value and excellence in preclinical drug development services. SNBL USA had confirmation, following the FDA’s September 2011 follow-up and general surveillance inspections, on closure for seven of the nine items. All that was left to do was to finalize the report amendments, which were completed and submitted in May 2012.
“SNBL USA has been working closely with the FDA since the issuance of the warning letter to demonstrate our full GLP compliance and achieve closure on the 2010 warning letter,” said Dr. Thomas Beck, SNBL USA president and COO. “We were confident in our ability to implement the appropriate corrective actions and at the same time improve our 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.”
Date: November 15, 2012
Source: SNBL USA Ltd.