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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 ...
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    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...
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    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...
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    Updated FDA Manual Offers Inside Look at Inspection Protocols

    The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect. The 127-page chapter offers the basics for how FDA inspectors should go about conducting what it calls, a "careful, critical, official examination of a facility to determine its compliance with laws administe...
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    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...
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    FDA to Drug Manufacturers: Beware Water-Borne Contaminants

    With a crop of recent product recalls due to Burkholderia cepacia complex (BCC) contamination, the US Food and Drug Administration (FDA) on Monday warned drug manufacturers of non-sterile, water-based drug products of the dangers that BCC and other water-borne opportunistic pathogens pose. “BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents,” FDA said in a stat...
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    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...
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    How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains

    During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories. The 12-page guidance, first proposed in January 2015, notes that the risk of cross-conta...
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    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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    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...
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    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...
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    Chinese Heparin Sourcing Questions Resurface After ANSM Inspection

    France's National Agency for Medicines and Health Products Safety (ANSM) raised two critical deficiencies over a Chinese pharmaceutical company’s manufacture of heparin, which harkens back to the scandal from 2007 and 2008 when heparin sourced from Chinese manufacturers killed 149 Americans. Following the December inspection of Dongying Tiandong Pharmaceutical Co.’s Dongying City-based manufacturing site, the site has been issued a statement of non-compliance and cannot ...