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    FDA Warns Pennsylvania Drugmaker Over GMP Violations

    The US Food and Drug Administration (FDA) last month warned Vilvet Pharmaceuticals over good manufacturing practice (GMP) issues and for failing to list two of its products with the agency.   The warning letter comes after a 10-day inspection of Vilvet’s Chester Springs, PA facility in June 2018.   According to FDA, Vilvet failed to establish and follow adequate quality control practices, including failing to review batches of drugs made by a contract manufacturer....
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    FDA Warns Spanish Firm Over GMP, Data Integrity Issues

    The US Food and Drug Administration (FDA) this month warned Spanish over-the-counter (OTC) drugmaker Proandre SL over good manufacturing practice (GMP) and data integrity issues that landed the firm on import alert in November.   FDA inspected Proandre’s Barcelona facility over the course of four days last June, finding that its OTC Proandre antibacterial soap and hand sanitizer liquid are adulterated and misbranded. Two other products are cited in the warning letter a...
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    FDA Warns Two Drugmakers for GMP Violations

    The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...
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    Additional Cancer Cases Linked to Use of Breast Implants, FDA Finds

    The US Food and Drug Administration (FDA) sent a letter to health care providers on Wednesday to raise awareness on additional cases of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). The letter addresses the last update on medical device reports (MDRs)—otherwise known as adverse event reports—submitted to FDA’s Center for Devices and Radiological Health (CDRH) regarding BIA-ALCL. The September 2018 update reported on a total of 660 MDRs of BIA-ALCL...
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    FDA Warns Company for Failing to Complete Postmarket Requirement

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Lymol Medical Corporation for failing to comply with the milestone date in the completion of a postmarketing requirement (PMR) for its sterile talc powder. FDA said the company did not demonstrate a good cause for its failure to complete the study, which was supposed to be a risk assessment study on the lead content of sterile talc powder in line with ICH’s Q3D Elemental Impurities gu...
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    FDA Flags Higher Death Rates Linked to Use of Abiomed Heart Pump in Post-approval Study

    A temporary heart pump manufactured by Massachusetts-based Abiomed prompted a US Food and Drug Administration letter to health care providers on Monday over an increased rate of mortality. The letter cites interim results from Abiomed’s January report on a post approval study (PAS) that was mandated by the agency as a condition for the 2017 FDA approval of the Abiomed Impella RP System. “A total of 44 out of 60 patients (73.3%) survived to 30 days post device explant...
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    FDA Warns Chinese OTC Drugmaker, Florida Fertility Center

    The US Food and Drug Administration (FDA) last month sent warning letters to Chinese over-the-counter (OTC) drugmaker Hangzhou Guoguang Touring Commodity Co. and the University of Miami Reproductive and Fertility Center.   Hangzhou Guoguang   The warning letter comes after FDA placed Hangzhou Guoguang on import alert in October following an inspection of the company's Zhejiang facility over four days last April.   According to the warning letter, Hangzhou Guog...
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    FDA Launches Probe into Drug-containing Balloons, Stents

    Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types. All-cause patient mortality rate at two years “significantly increased” and “increased further” after up to five years, following use of paclitaxel-coated balloons or p...
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    FDA Warns Korean Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 28 November to Korea-based Barox Co., Ltd. for significant violations of current good manufacturing practice (CGMP) regulations. FDA said the firm relabels over-the-counter drug products manufactured by a contract manufacturer and then distributes the drugs to the US. “You have no written documents describing roles and responsibilities of a Quality Control Unit (QCU). All of your empl...
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    FDA Warns Korean Drugmaker Over Poor Aseptic Practices, Patchy Lab Records

    South Korea-based Hanlim Pharm Co. drew a US Food and Drug Administration (FDA) warning letter over poor aseptic practices and inadequate processes for documentation, among other violations of good manufacturing practice (GMP). The FDA inspection of the company’s drug manufacturing facility in Gyeonggi-do earlier this year concluded that similar GMP violations had been observed during FDA visits to the site in 2014 and 2016. The repeat observations underscore a need for ...
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    CBER Sends Untitled Letter to Marketer of Unapproved Allergy Spray

    The US Food and Drug Administration’s (FDA) Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) sent an untitled letter to the owner of two websites purporting to sell allergy treatments that have not been approved.   The company Telogenes, LLC boasts that its product, known as Ollereg, “contains FDA-approved allergens used off label for oral immunotherapy,” among other claims, but FDA raised concerns.   “Based on t...
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    FDA Warns BD for GMP Violations at Lock Flush Syringe Facility

    The US Food and Drug Administration (FDA) has warned medical device maker Becton Dickinson (BD) for good manufacturing practice (GMP) violations at the company’s Franklin, Wisconsin facility.   The warning letter comes after two-and-a-half-month inspection this summer during which FDA found the company’s pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe products to be adulterated.   The warning is BD’s second in 2018 after...