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    FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires

    Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administration (FDA) to issue three warning letters for good manufacturing practice (GMP) violations to an over the counter drug manufacturer, a finished drug manufacturer and an API manufacturer in the US.   The recipients of the warning letters, w...
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    Three foreign OTC firms slapped with warning letters for GMP testing violations

    Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one led the US Food and Drug Administration (FDA) to issue three warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.   The recipients of the warning letters, which were all issued in mid-September, include Laboratorio Pharma International in Tegucigalpa, Honduras, a manufacturer of antibiotics and ...
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    Two more stem cell firms slapped with untitled letters

    Untitled letters issued to two firms for marketing unapproved stem cell products signal that some in the industry are undeterred by the US Food and Drug Administration’s (FDA) efforts to get these products approved or off the market.       The letters join four others from the Center for Biologics Evaluation and Research (CBER) in recent months to clinics marketing unapproved stem cell products after an enforcement grace period ended on 1 June. (RELATED: CBER targets...
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    Antifreeze and APIs don't mix, FDA tells Syntec

    The US Food and Drug Administration has warned New York-based pharmaceutical manufacturer Syntec for a litany of good manufacturing practice (GMP) problems. The agency says that issues related to how the firm handles active pharmaceutical ingredients (API) compromise the safety of the drugs produced at the site.   Among the problems found by FDA at the firm’s site in Farmingdale, NY, were inadequate contamination safeguards, as well as lax cleaning and testing proced...
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    FDA’s document-based inspections prompt warning letters for GMP violations

    The US Food and Drug Administration (FDA) on 13 April warned South American active pharmaceutical ingredient (API) manufacturer Proquimes SA Productos Quimicos Especializados SA for a multitude of good manufacturing practice (GMP) violations. The letter joins three others the agency has issued since the beginning of the year that are based solely on a records review and not onsite inspections.   The warning letters signal the agency’s increasing reliance on a review of...
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    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...