Dive Brief:
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France's National Agency for Medicines and Health Products Safety (ANSM) discovered two critical compliance violations at a Chinese pharmaceutical manufacturing facility which produces heparin, a blood thinner.
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The inspection of the site, run by Dongying Tiandong Pharmaceutical, found evidence suggesting tests of crude heparin supplies showing traces of ruminant DNA had been manipulated. ANSM recommended a product recall should be considered given the deficiencies.
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Tainted heparin sourced to Chinese manufacturers led to the deaths of 149 Americans in 2007 and 2008, prompting the FDA to develop guidance for the manufacturing of heparin.
Dive Insight:
In its report following the inspection, ANSM found 10 deficiencies in total, including 2 critical violations.
In the first critical violation, tests of crude heparin showing the presence of ruminant DNA appeared to have been manipulated. Additionally, Dongying's system for ensuring the traceability of the crude heparin used in its processing was reportedly "very weak."
Overall, Dongying misunderstood basic GMP principles governing the handling of out of specification results. Taken together, the French regulatory suggested a product recall should be considered.
Recently, concerns have mounted over the quality of pharmaceutical manufacturing in China. The FDA has issued a number of warning letters citing GMP violations over the past year, and lists 42 Chinese plants on its import ban list. The Dongying facility is not currently listed.
