22/23 February 2024
The heparin scandal was one of the worst drug incidents of the last 20 years. In 2008, 81 people died due to administration of heparin which had contained over-sulfated chondroitin sulfate, a substance that is hard to differentiate from heparin analytically. Raw heparin had been cut with this chondroitin derivative in order to maximize profits. The scandal had a lasting effect on the regulatory environment back then: the FDA established inspections in India and China and issued the revision or complete rewrite of several guidelines. In the EU, the Directive for Prevention of Falsified Medicinal Products was published and implemented in July 2011 (FDA Inspections in China - Consequences from the Heparin Case). Still, more and more "black sheep" were discovered amongst the API manufacturers who produced heparin. One of the most recent cases is that of a Chinese manufacturer who received a GMP non-compliance report on February 25th, 2016 after having been visited by European GMP inspectors (Chinese Heparin Manufacturer again involved in Falsification and GMP Non-Compliance).
Recently, the FDA issued another Warning Letter concerning heparin. Recipient this time was the Chinese contract laboratory Shandong Analysis and Test Center. The inspectors found the following severe GMP violations:
Until all corrective measures have been implemented and following the GMP compliance of Shandong Analysis has been confirmed, the FDA won't process any authorisation applications listing this contract laboratory.