U.S. Food and Drug Administration (FDA) officials inspecting Chinese drug maker Dongying Tiadong Pharmaceuticals Co., Ltd., found “significant deviations” from current good manufacturing practices in its manufacturing of the blood thinner heparin. Dongying Tiadong was warned by French regulators over similar violations last March.
The agency cited the company in its testing of crude heparin batches saying it failed to adequately investigate and document out-of-specification (OOS) results “repeatedly and without justification.”
“Disregarding the OOS results, and resampling and retesting without scientific justification, constitutes ‘testing into compliance.’ This practice is unscientific and objectionable under current good manufacturing practices,” the agency said in a warning letter to company officials.
The FDA also warned Dongying Tiadong that it failed to ensure that test procedures were scientifically sound and conformed to established standards of quality and/or purity. Furthermore, the company was cited for inadequately monitoring its crude heparin suppliers.
Heparin is a widely used anticoagulant that is commonly used during surgical procedures and in patients undergoing dialysis. About 12 million Americans are treated with the drug each year.
In 2008, heparin produced by Chinese manufacturers and later found to be contaminated, killed nearly 150 Americans who were administered the tainted product. The FDA’s warning letter shows that problems continue to persist with China’s producers of heparin.
Despite the concerns, the FDA has not banned the company’s imports to the U.S., but it did warn that if the violations were not corrected in a timely manner it could “result in FDA refusing admission of articles manufactured at Dinging Tiandong Pharmaceutical Co.”