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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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    FDA warns Florida firm for GMP, QS violations

    In a lengthy warning letter issued to Tarmac Products, Inc, a Florida-based contract manufacturer, the US Food and Drug Administration (FDA) cites the company for a dozen good manufacturing practice (GMP) and quality system (QS) violations.   The warning letter, first published Tuesday, was sent last November based on issues observed during a two-and-a-half-week inspection in September 2019, several of which are repeat observations from previous inspections in 2015 and...
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    FDA warns COVID trial sponsor for failing to submit IND

    The US Food and Drug Administration (FDA) last month warned a clinical trial sponsor for failing to submit an investigational new drug (IND) application for a study of a product to treat COVID-19.   In its warning letter to KDunn and Associates, P.A. dba HealthQuilt, FDA said it observed “objectionable conditions” during an August inspection related to a trial the company sponsored titled “An Open-Label Pilot Study to Assess the Efficacy and Safety of [redacted] in Sub...
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    OPDP warns Paragard maker over promotional video

    A sponsored video that aired on NBC’s Boston affiliate in October has landed CooperSurgical a warning letter from the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) for failing to include risk information about the company’s Paragard intrauterine device (IUD).   The warning letter is the second sent by OPDP in 2021 and is the second enforcement letter sent to CooperSurgical concerning Paragard. In 2019, OPDP sent the company an unt...
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    OPDP warns AcelRx over Dsuvia promotional materials

    In its first warning letter of the year, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week cited AcelRx Pharmaceuticals over promotional materials for its opioid analgesic Dsuvia (sufentanil sublingual tablet).   Specifically, the warning letter cites the company for false and misleading claims made in banner ads and a tabletop display that feature a tagline promoting the ease of administration of Dsuvia as “Tongue a...
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    FDA warns Florida drugmaker for GMP violations

    The US Food and Drug Administration (FDA) last month warned Hialeah, FL-based drugmaker Allay Pharmaceuticals over good manufacturing practice (GMP) issues identified during a rare on-site inspection during the COVID-19 pandemic.   The warning letter cites the company for four issues observed during an inspection in May 2020 involving subpotent products and active pharmaceutical ingredient (API) testing lapses.   FDA says the company “failed to establish written pr...
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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 warns Battelle over EUA conditions for N95 decontamination system

    The US Food and Drug Administration (FDA) on Wednesday warned Battelle Memorial Institute for failing to comply with some of the conditions of its emergency use authorization (EUA) for its decontamination system for N95 respirators.   The warning letter is the first FDA has issued concerning a product being used under an EUA during the COVID-19 pandemic.   In March, Battelle became the first organization to receive an EUA for a decontamination system for N95 respir...
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    FDA warns Sprout for misleading Addyi come-on

    Sprout Pharmaceuticals’ promotion of Addyi both mischaracterizes the drug’s indication and downplays potential serious adverse events associated with its use, according to a warning letter from the US Food and Drug Administration (FDA).   Sprout Pharmaceuticals markets the non-hormonal drug Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. To meet HSDD criteria, low desire must cause marked distress or i...
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    FDA warns Mylan, Acella Pharmaceuticals over GMP violations

    The US Food and Drug Administration (FDA) last month warned Mylan Laboratories and Acella Pharmaceuticals over good manufacturing practice (GMP) violations.   Mylan Laboratories   FDA’s warning letter to Mylan comes after the agency inspected the company’s facility in the Sangareddy District of Telangana, India over the course of a week last February.   The warning letter, which cites the company for issues related to its cleaning procedures and handling of r...