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    FDA Warns Doctor Over Unapproved Device

    In a 14-violation US Food and Drug Administration (FDA) warning letter, the agency flagged a doctor’s website for significant deviations from FDA quality system requirements and good manufacturing practices (GMP), as well as illegally marketing an unapproved device for a complication of breast implants. The warning letter was issued to Mark Berman of Beverly Hills, California for marketing the implantable Pocket Protector device online with claims and use indications ...
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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 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 Warns Chinese Manufacturer Over Product Testing Failures

    China-based Cao Medical Equipment drew a US Food and Drug Administration (FDA) warning letter after it continued to ship adulterated drugs despite promising to “immediately stop.”    The warning letter cites significant violations of good manufacturing practices at a facility in Hebei, China that resulted in adulterated drug products. It comes after the firm failed to ease FDA’s concerns in its response to a July Form 483. The firm was placed on import alert last month...
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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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    Mylan Discontinues, Transfers Products In Wake of FDA Warning Letter

    A recently issued US Food and Drug Administration (FDA) warning letter escalated previously observed issues around quality control at Mylan Pharmaceuticals’ manufacturing facility in Morgantown, WV, to significant violations of good manufacturing practices (GMP).   The warning letter posted on Tuesday took issue with the firm’s May response to the 13 inspectional citations outlined in a Form 483, following an inspection conducted by FDA investigators between March an...
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    FDA Dings Surgical Instrument Manufacturer Over 'Unacceptable' Timelines

    American Contract Systems provided “unacceptable” timelines to correct US Food and Drug Administration (FDA) inspectional citations, according to a new FDA warning letter.   The Pennsylvania-based manufacturer of surgical trays and kits indicated for hospital use drew a total of five significant violations, following the quick turnaround on the warning letter. FDA investigators inspected the firm’s manufacturing facility in Zelienople over the course of two weeks from ...
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    FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

    Device firms in Sweden, Canada, Spain and the UK separately drew four US Food and Drug Administration (FDA) warning letters over good manufacturing practice (GMP) violations.   The GMP violations cited in the warning letters posted Tuesday stem from inspectional observations first noted in FDA Form 483s issued to each of the four device manufacturing facilities, following the site visits investigators conducted during 2017 and 2018.   Most of the firms issued res...
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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 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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    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...
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    FDA Warns Datascope Over QSR, Reporting Violations

    The US Food and Drug Administration (FDA) sent a warning letter to New Jersey-based medical device maker Datascope Corporation over quality system regulation (QSR) and medical device reporting (MDR) violations.   Datascope, which was bought by the German multinational Maquet in 2008, markets a variety of cardiovascular devices such intra-aortic balloon catheters and cardiopulmonary bypass tubing packs.   The warning letter comes after an inspection of the company's...