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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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    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...
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    OPDP sends first untitled letter of 2020 to Xeris over Gvoke TV spot

    Xeris Pharmaceuticals last week received the first untitled letter sent by the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) in 2020 over claims made in a television ad for its Gvoke (glucagon) pre-filled syringe.   The letter is only the second enforcement letter sent by OPDP this year after the office warned Outlook Pharmaceuticals for omitting risk information in a sponsored link on Google, marking a particularly light year for...
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    FDA warns California-based CDMO, Mexican drugmaker

    The US Food and Drug Administration (FDA) earlier this month warned two companies, contract development and manufacturing organization (CDMO) Stason Pharmaceuticals and Mexican drugmaker Signa SA de CV.   Stason Pharmaceuticals, Inc.   In its warning letter to Irvine, CA-based CDMO Stason Pharmaceuticals, FDA cites the company for product testing and data integrity issues uncovered during a three-week inspection last October.   According to FDA, the company w...
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    FDA warns Takeda over aseptic processing, inadequate investigations

    The US Food and Drug Administration (FDA) last week warned Japanese drugmaker Takeda Pharmaceutical over good manufacturing practice (GMP) violations observed during an inspection of its Hikari, Yamaguchi facility last November.   Specifically, the warning letter cites the firm for three violations relating to its procedures for aseptic manufacturing and investigations into unexplained discrepancies and equipment malfunctions.   “Our inspection found that your Qual...
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    FDA Warns Massachusetts PET Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Woburn, Massachusetts-based PETNET Solutions Inc. after an inspection last spring uncovered unclean conditions and failures in environmental monitoring for the positron emission tomography (PET) drug manufacturing site’s aseptic operations. The letter notes that the FDA inspector “observed a state of disrepair and lack of cleanliness” at the site, while “sporeforming fungi were repeat...