• Regulatory NewsRegulatory News

    MHRA Investigates GMP Deficiency Trends From 2016

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs) in 2016. Compared to 2015, MHRA conducted 21 more total GMP inspections in 2016, and three more foreign inspections. But like in 2015, the most cited deficiency for 2016 was related to companies’ quality systems. Sterility assurance, producti...
  • Regulatory NewsRegulatory News

    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 ...
  • Feature ArticlesFeature Articles

    510(k) Submissions: Current Trends and Tips

    This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process. This past year has seen the 510(k) submission process evolve and the US Food and Drug Administration (FDA) take a more stringent stance on what submission materials will be accepted. To offset some of the technical impact of a stricter adherence to a more rigorous...
  • Feature ArticlesFeature Articles

    A Lifecycle Approach to ANDA Filings: Lessons Learned

    This article discusses the benefits of implementing a lifecycle approach to ANDA filings to avoid refuse-to-receive notices and deficiencies, ensuring readiness for preapproval inspections. With more than 2,000 Abbreviated New Drug Applications (ANDAs) awaiting review or inspections in 2012, the US Food and Drug Administration (FDA) received additional resources to tackle this backlog with the enactment of the Generic Drug User Fee Amendment (GDUFA ), designed to spee...
  • Chinese Firm Used White Out to Change Regulatory Records, FDA Says

    Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly interfering with an investigation of the facility by using white-out on regulatory documents, among other serious alleged violations. The alleged deficiencies are outlined in a 14 November 2012 warning letter to Shanghai Huhui, released to the public on 5 December 2012. In ...
  • Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, CGMP, Design Deficiencies

    The US Food and Drug Administration (FDA) released five warning letters previously issued to companies in the healthcare product sector, including three medical device companies, one pharmaceutical distributor and one supplement manufacturer. William Demant Holdings A/S (Medical Device) FDA's warning letter to William Demant , a Danish medical device manufacturer, cited deficiencies at its Oxford, UK facility found during two December 2011 inspections. The company, w...
  • FDA Cites Military-tech Company for Marketing Medical Device Without Approval

    A company marketing several medical devices intended to be used in combat situations has been cited by the US Food and Drug Administration (FDA) for marketing one without having sought approval from the agency and manufacturing numerous others in violation of current good manufacturing practices. In a warning letter released 9 May, FDA said Virginia-based manufacturer H&H Associates does not have "an approved application for premarket approval in effect" pursuant to ...
  • Six Dietary Supplement Manufacturers Cited by FDA for Promoting Unproven Claims, CGMP Violations

    The US Food and Drug Administration (FDA) fired off numerous warning letters to dietary supplement manufacturers this week. While its actions against ten manufacturers of dimethylamylamine (DMAA) garnered significant attention , FDA also sent warning letters to six other dietary supplement manufacturers for allegedly violating numerous regulations under the Federal Food, Drug and Cosmetic Act (FDCA) . Manufacturer Vitality Distributing, Inc.,  received an FDA warn...
  • FDA Warning Letter Cites Company for Breaking HCT/P Regulations

    A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells, tissues or cellular and tissue-based products (HCT/Ps). FDA's warning letter specifically cites Young's Owner and Medical Director Thomas E. Young for removing, reprocessing and injecting patients with their own adipose tissue (lipoaspirate), from which Young isolated stem ce...
  • DOJ Files 'Groundbreaking' Consent Decree Against Ranbaxy, Company Agrees to 'Remedy Deviations'

    The US Department of Justice (DOJ) filed a Consent Decree of Permanent Injunction against Ranbaxy, an Indian generic drug manufacturer, with the US District Court of Maryland on 25 January. The action was taken on behalf of the US Food and Drug Administration (FDA), which had found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and a US-based Ranbaxy subsidiary's facility in New York. The consent decree requires Ranbaxy to c...