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    E&C Leaders Seek FDA Briefing on Contaminated Sartans

    A bipartisan group of lawmakers who serve on the US House Committee on Energy and Commerce (E&C) sent a letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday to request a briefing on the sartan safety issues that prompted a string of recalls worldwide. “Beginning in July 2018, there have been at least 15 recalls issued for a variety of angiotensin II receptor blockers (ARB), which are generally used to treat high blood pressure,” the E...
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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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    EU Restricts Slovak Manufacturer’s GMP Certificate Over Spate of Deficiencies

    Unimed Pharma, a Slovakia-based pharmaceutical manufacturer, drew a statement of noncompliance after an inspection revealed two critical and 21 major good manufacturing practices (GMP) deficiencies. The statement of noncompliance took issue with the firm’s manufacturing operations for sterile products, including aseptically prepared small volume liquids and batch certification. The statement was issued by the Slovakian State Institute for Drug Control (SIDC), following ...
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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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    Updated: FDA Flags Pfizer’s Hospira Plant in Kansas Over Repeat 483 Citations

    A US Food and Drug Administration (FDA) inspection at the McPherson, KS plant of Pfizer’s Hospira business revealed seven repeat FDA Form 483 citations dating back to 2012. FDA investigators conducted an inspection of the human sterile drug manufacturing site from late July to early August 2018, with the agency posting the Form 483 to its website Friday. The latest 483 comes after Hospira’s Kansas plant drew an FDA warning letter last year, with significant violations...
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    Medtronic Fronts $51M to Resolve DOJ Case Over Unapproved Device Uses

    Medtronic agreed to pay $51 million in a case brought on by the US Department of Justice (DOJ) over introducing an adulterated medical device into interstate commerce. At the center of the off-label marketing litigation is the US Food and Drug Administration's (FDA) 2005 premarket approval on an use indication for a neurovascular device manufactured by ev3, which was acquired  by Covidien in 2010, which Medtronic acquired  in 2015.  ev3 launched a sales and marketi...
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    CDRH Touts Uptick in Foreign  Device Inspections

    The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report.   “As medical device manufacturing has become an increasingly global enterprise, the FDA has taken forceful action to increase inspections of medical device firms, especially those located in foreign countries,” said Jeff Shuren, director at the FDA’s Center for Devices and Radiologi...
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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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    Millions of Drugs, Medical Devices Detained in 116-Country Operation

    A total of 465 websites are the target of a global operation led by Interpol to crack down on the illegal sale of drugs, including opioids and cancer medications, and has resulted in the detainment of more than 10.1 million illegal dose units of drugs and medical devices.   The US Food and Drug Administration (FDA) also posted seven warning letters on Tuesday as part of the international collaboration dubbed Operation Pangea X, FDA spokesperson Jeremy Kahn confirmed wi...
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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...