In the close out document – which was sent last week – the Food and Drug Administration (FDA) confirmed the preclinical contract research organisation (CRO) has fixed the issues that earned its primate and small animal laboratory in Everett, Washington a warning letter in August 2010.
Company president Thomas Beck told Outsourcing-pharma.com that although SNBL USA continued to attract preclinical projects over the past two years, a small amount of work had gone elsewhere.
“We have several clients that have wanted to work with us due to our relationship and scientific expertise, however their Regulatory departments look at the FDA website when evaluating potential partners and in some cases this has blocked the scientists from working with us."
“We now have the signed letter from the FDA stating that all items have been addressed and adequately corrected” Beck continued, adding that “the FDA website will take a while to get changed. However we are permitted to show the “Close Out letter” to our clients to reassure them. We feel strongly that this will open doors that were previously closed.”
To resolve the issues detailed in the 2010 warning letter SNBL USA employed external experts identified by Lachman Consultants to make sure staff were fully trained in all relevant good laboratory practices (GLP) codes, including 21 CFR Part 58 and Part 11.
Beck said: “Last year when I came to SNBL USA we worked with consultants to evaluate all of our GLP systems. Not just the issues in the warning letter. Then we developed a plan for sustainable GLP compliance that produced corrective actions for any gaps that were identified. We then executed those steps.”
In addition to the expanded in-house GLP scheme – which sees staff trained four times a year – SNBL reviewed all of its SOPs, implemented new auditing and reporting processes, invested in animal housing, IT and monitoring equipment and introduced a maintenance programme.
In October these efforts earned the Everett facility - and a site SNBL operates in Alice, Texas -Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation for animal welfare.