SNBL USA, Ltd., a subsidiary of Shin Nippon Biomedical Laboratories, has received a letter from the FDA indicating that it has successfully resolved all issues identified in an August 10, 2010, warning letter.
SNBL USA has systemically rebuilt the operation and re-established its preclinical drug development services, according to a company statement. Following the FDA’s September 2011 follow-up and general surveillance inspections, seven of the nine items were resolved. A report to finalize the amendments was 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’s president and chief operating officer. “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.”