Heparin makes its way back into the news in an FDA warning letter to API maker Scientific Protein Labs. The letter addressed to CEO David Strunce is dated Jan. 20 and refers to a Waunakee, WI, plant inspection that ran July through September 2010.
The FDA's chief complaint involves complaint investigations. SPL waited almost a year before looking into an October 2008 complaint of oversulfated chondroitin sulfate contamination in a lot of heparin sodium USP. In addition, the investigation excluded another lot of heparin based on the same crude lot. Nine more months went by--until May 2010--before the company considered the other finished lot that was associated with the same contaminated crude lot.
SPL was involved in the 2008 heparin contamination incident that killed or sickened dozens of people in the U.S. in 2008.
"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," writes Gerald Berg, director for FDA's Minneapolis District, in the warning letter.
SPL had told the FDA after the inspection it would revise procedures, directing any SPL employee to inform QA of customer complaints. However, the FDA counters in the warning that SPL's handling of the complaint indicates a need for the drugmaker to evaluate training "across all departments" about when to contact the quality unit.
"FDA expects that your corporate management will immediately undertake a comprehensive evaluation of your quality system to ensure comprehensive compliance with CGMP."
- here's warning letter WL 11-09