Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 FDA Closes Out SNBL Issues | Contract Pharma

What are you searching for?

Sign in
Breaking News

FDA Closes Out SNBL Issues

2010 warning letter sited nine issues

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

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.”

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics