Compliance Management

FDA Sends Warning Letter to Chinese Heparin Manufacturer

Nov 29, 2016

Regulatory Affairs Professional Society

The U.S. Food and Drug Administration sent a warning letter earlier this month to a China-based manufacturer of heparin, who was also warned by French regulators last March, according to the Regulatory Affairs Professional Society.

The letter says the company used crude heparin batches that potentially were out of specification (OOS) to manufacture heparin sodium for the U.S. market and shows that previous issues related to heparin sourced from Chinese API manufacturers — linked to the deaths of nearly 150 Americans in 2008 — have persisted, the story said.

The warning letter stated: “Our investigator found that your firm repeatedly, and without justification, resampled and retested crude heparin batches when your quantitative polymerase chain reaction (Q-PCR) test for ruminant DNA exceeded your established specification limit. You neither evaluated the initial sample OOS, nor conducted retesting of the initial original sample to confirm it. Instead, you resampled until you obtained a passing result.”

FDA has not banned the company’s products from entering the U.S., noting, “Failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Dongying Tiandong Pharmaceutical Co.”