• Regulatory NewsRegulatory News

    Fresenius Kabi pays $50 million to settle criminal charges

    An Indian drug manufacturer has agreed to pay $50 million in fines and forfeitures, the US Department of Justice announced Tuesday. Fresenius Kabi Oncology Limited (FKOL) plead guilty to concealing and destroying records; the charges came in the wake of a 2013 US Food and Drug Administration (FDA) inspection of its plant in Kalyani, India.   “By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA’s regulatory authority and prevent the FDA from do...
  • Stem cell and allergy clinics receive CBER untitled letters

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) has issued untitled letters to a firm marketing regenerative medicine products and to a company selling extracts for immunotherapy.   On 25 January, CBER warned the owner of a California-based company called The Body Building, Inc. for marketing “BioGenix regenerative medicine products” to treat a variety of conditions including autoimmune disease, diabetes, Parkinson’s di...
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    Azurity garners OPDP untitled letter for problematic emails

    Marketing Xatmep (methotrexate oral solution) to health care providers without giving a full presentation of the drug’s serious risks has garnered Azurity Pharmaceuticals an untitled letter from the US Food and Drug Administration (FDA).   In the letter dated 24 November 2019, FDA’s Office of Prescription Drug Promotion (OPDP) references promotional materials sent to healthcare professionals via email by Massachusetts-based Azurity.   Xatmep is indicated as part of...
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    FDA sends first warning letters for fraudulent marketing of antibody tests

    The US Food and Drug Administration this week issued its first set of warning letters for marketing adulterated or misbranded COVID-19 antibody tests.   The letters, sent to Medakit Ltd. of Hong Kong,  Antibodiescheck.com of United Arab Emirates, and Sonrisa Family Dental dba www.mycovidtest19.com of Chicago, cited a range of violations. These included offering test kits for sale in the US directly to consumers for at-home use without marketing approval, cleara...
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    FDA Warns Drug Manufacturers as FTC Warns CBD Advertisers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to South Korea-based drug manufacturer Enprani Co. and China-based drug manufacturer Hangzhou Badi Daily Use Chemical Company. Meanwhile, the Federal Trade Commission (FTC) on Tuesday said it sent warning letters to three unnamed companies for illegal advertising of products containing cannabidiol (CBD). The letter for Enprani, which follows a five-day inspection last March, shows how...
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    Study Finds Stimulants in Supplements After FDA Action

    A study published in JAMA Internal Medicine on Monday raises questions about the effectiveness of the US Food and Drug Administration’s (FDA) actions to address stimulants found in dietary supplements.   While FDA often issues public notices or takes enforcement action aimed at specific companies or products, from 2013-2016 the agency issued public notices warning consumers about four sympathomimetic stimulants found in dietary supplements.   None of the stimulan...
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    FDA Warns Imprimis for False and Misleading Website and Twitter Promotions

    The US Food and Drug Administration (FDA) late last month sent a warning letter to San Diego-based Imprimis Pharmaceuticals for false and misleading claims made on the company’s website and Twitter account, among other violations. FDA said that for two products – "Simple Drops" and "Klarity C-Drops" – the company claims they are made with FDA approved components or are FDA-approved, "when that is not the case."  In addition, FDA said Imprimis' website makes false...
  • Feature ArticlesFeature Articles

    How to Conduct Data Integrity Investigation Interviews

    Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel. Introdu...
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    FDA Warns Canadian, Indian Drugmakers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to Burlington, Ontario-based Aztex Enterprises and Raigad, India-based Kim Chemicals Private Ltd. Kim Chemicals According to the warning letter sent 16 October, FDA said that although Kim Chemicals promised to set up a GMP system with written procedures, the company’s plan lacks details. The firm on 21 August was added to FDA's import alert list for drugs that have not met GMPs. ...
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    FDA Warns Three Device Companies From US, Germany and France, One Indian API Manufacturer

    The US Food and Drug Administration (FDA) this week released three warning letters sent to medical device manufacturers, including Florida-based UVLrx Therapeutics, Inc., Germany-based DRG Instruments GmbH and France-based ELITech Group SAS, as well as one to the Vapi, India-based active pharmaceutical ingredient (API) manufacturer Vital Laboratories. UVLrx Therapeutics The inspection conducted at UVLrx from 27 March 2017 to 4 April 2017 to assess a clinical study t...
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    FDA Warns Swedish IVD Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II  in vitro  diagnostic (IVD) devices. The warning, following an inspection last January, features at least five violations, including one related to the company’s decision to not recall an assay used to detect anti-nuclear antibodies after receiving complaints of a higher incidence of false p...
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    FDA Warns Korean, Chinese Drugmakers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations. For Wuxi City-based Wuxi Medical Instrument Factory, FDA last March uncovered four violations, including one that involved the firm lying to FDA about when some documents were created. "The records, covering January to March, 2017, were signed by two employees, and in...