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SNBL USA, Ltd. Announces Official Letter From the FDA Declaring All Issues Resolved


11/14/2012 11:56:01 AM

Everett, WA – November 14, 2012 – SNBL USA, Ltd., a wholly owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd., today 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.”

SNBL USA is uniquely positioned to partner with its clients in the development of therapies using nonhuman primates. SNBL USA’s purpose-built facilities, highly trained staff and managed supply of nonhuman primates are optimized to deliver the highest quality preclinical research in the industry.

About SNBL USA, Ltd.

Headquartered in Everett, Wash., SNBL USA, Ltd., offers a unique range of safety assessment services to fulfill its commitment to help free patients from suffering. Managed and operated by a team world renowned for its wide-ranging nonhuman primate (NHP) experience and expertise, SNBL offers programs ranging from regulatory toxicology to customized study designs. SNBL’s specialized capabilities include safety assessment of biologics, reproductive toxicology, cardiovascular, respiratory and CNS pharmacology, immunotoxicology and carcinogenicity.


Read at BioSpace.com

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