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  • Regulatory NewsRegulatory News

    FDA: US Heparin Supply Not Impacted by African Swine Fever in China

    With shortage concerns looming, the US Food and Drug Administration (FDA) on Monday said that the US heparin supply is not being impacted by the African swine fever in China. “The majority of manufacturers reported no such issues related to African swine fever,” FDA said after reaching out to heparin suppliers. “FDA continues to be in regular contact with US heparin suppliers and manufacturers as this situation evolves.” The update from FDA follows a letter sent in ...
  • Regulatory NewsRegulatory News

    House Committee Seeks FDA Briefing on Heparin Supply

    The House Energy & Commerce (E&C) Committee leaders sent a letter on Tuesday to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless seeking further information on how FDA is monitoring the supply of the anticoagulant heparin. The letter notes how the US is reliant on China for its supply heparin, which in turn is reliant on China’s pig supply. Recently, China struggled to contain an outbreak of African swine fever and will lose about 150 million of i...
  • Regulatory NewsRegulatory News

    Chinese Heparin Manufacturer Receives Statement of GMP Noncompliance

    Sichuan, China-based Yibin Lihao Bio-technology Co. earlier this month received a statement of noncompliance with good manufacturing practices (GMP) from the Italian Medicines Agency. The statement followed an inspection at the firm’s crude heparin manufacturing site on 31 October 2018. The extraction of substance from animal sources, certain physical processing and packaging steps and biological testing were found to be noncompliant. The inspection identified 24 GMP...
  • Regulatory NewsRegulatory News

    Chinese Heparin Contamination Questions Return With New FDA Warning Letter

    The US Food and Drug Administration (FDA) released a warning letter on Wednesday for China-based heparin contract testing lab, Shandong Analysis and Test Center, reigniting a debate over whether the questionable sources of heparin that led to almost 100 American deaths a decade ago have been rooted out. Background In 2007 and 2008, heparin sourced from Chinese manufacturers was linked to the deaths, though House Energy & Commerce committee members expressed co...
  • Regulatory NewsRegulatory News

    House Committee Asks FDA for More Info on Contaminated Heparin Investigations

    Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed. In 2007 and 2008, heparin sourced from Chinese manufacturers was linked to the deaths of nearly 150 Americans. Questions of contamination resurfaced last year when French regula...
  • Feature ArticlesFeature Articles

    CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions

    To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DTAB Proposes Stipulations to Indian Plan for Permanent Licenses The Indian Drugs Technical Advisory Board (DTAB) has given its conditional support to end the need to renew licenses to make, sell and test drugs. DTAB is broadly in favor of the idea, but has suggested stipulations that are more burdensome than those proposed by the Drug Controller General of India (DCG...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March. The letter says the company used crude heparin batches that potentially were out of specification (OOS) to manufacture heparin sodium for the US market and shows that previous issues related to heparin sourced from Chinese active pharmaceutical ingredient (API) manufac...
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    Flying Insects and Chipping Paint: FDA Warns Chinese API Manufacturer

    Two of Xinxiang Pharmaceutical’s China-based manufacturing facilities received a US Food and Drug Administration (FDA) warning letter on 19 August after FDA inspectors found drug manufacturing equipment and facilities in such a state of disrepair as to be unsalvageable. The company, which previously received a Form 483 in 2015 and was placed on the import alert list in April, was found to be using “open equipment” for the manufacture of active pharmaceutical ingredi...
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    CFDA’s Domestic Pharma Manufacturing Site Inspections Decline Significantly

    China’s Food and Drug Administration (CFDA) in 2015 inspected less than half the number of pharmaceutical manufacturers as compared with 2014, according to a recently released annual report from the Center for Food and Drug Inspection of CFDA. The report claims that as the number of domestic inspections has decreased significantly, “the proportion of enterprises going through rectification inspection and receiving Warning Letters has significantly increased, with the rat...
  • Regulatory NewsRegulatory News

    FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers

    Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection. On Wednesday, FDA added Xinxiang Pharmaceutical Co. and  Xinxiang Tuoxin Biochemical Co., noting: “Only drug and drug products (i.e. adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are sub...
  • Regulatory NewsRegulatory News

    Congressmen Slam FDA’s Handling of Investigation Into Tainted Chinese Heparin

    Several members of the House Committee on Energy & Commerce are raising new concerns over the US Food and Drug Administration’s (FDA) investigation into intentionally adulterated Chinese heparin that led to the deaths of 149 Americans in 2007 and 2008. One of the lingering concerns in the letter sent to FDA Commissioner Robert Califf on Wednesday is that a lack of communication between FDA’s Office of Criminal Investigations (OCI) and its Center for Drug Evaluation and R...