Warning Letter WL 11-09 states that SPL waited almost a year before investigating a contamination complaint concerning a lot of heparin sodium. When it did investigate, it didn't check another lot made from the same crude lot. Eight months passed before that investigation began.
"The manner in which you addressed this problem is very worrisome with respect to the timeliness of the investigation, the identification of all potentially affected drugs, and implementing appropriate actions to resolve these issues," the letter states.
In addition, SPL failed to audit a contract testing lab, a violation of its own procedures. When it did so during the FDA inspection, it discovered "critical and major" deficiencies. They led to SPL submitting inaccurate data to the agency, including "numerous instances" of reports that documented passing results of tests when in fact the results indicated failure.
"We are concerned about your firm's fundamental understanding of what is required by your Quality Unit and the regulatory expectations for a firm that enters into agreements with contract testing laboratories," says the warning letter. "You are ultimately responsible for the quality of your products and the reliability of test results."