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    Power Failures Land India-Based Cancer API Manufacturer a Form 483

    Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site. “During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing aud...
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    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...
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    FDA Warns Jubilant, Pfizer Subsidiary in India

    The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...
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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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    Continuous Manufacturing: FDA Drafts Quality Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic drugs.   The 27-page draft guidance is part of FDA’s effort to encourage the adoption of continuous manufacturing and covers quality considerations for solid oral small molecule drugs and builds on feedback from a public consultation launched in 2017.   According to FDA Commissioner Scott Gottlieb and C...
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    FDA Defends its Efforts to Ensure Generic Drug Quality

    The US Food and Drug Administration (FDA) on Friday sought to quell a series of media reports raising questions with the agency’s declining inspectional work around the globe and concerns with the agency’s oversight of generic drugs. FDA Commissioner Scott Gottlieb and FDA’s Center for Drug Evaluation and Research Director Janet Woodcock wrote in an extended statement that recent press reports inaccurately raised questions with the quality of the US drug supply and wron...
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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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    FDA Warns Ocular Therapeutix Over Failure to Comply With Postapproval Requirements

    Ocular Therapeutix drew a US Food and Drug Administration (FDA) warning letter for failing to comply with post-approval study requirements (PAS) set as part of its ReSure Sealant’s conditional approval. The warning letter, dated October 2018, cites the company’s failure to collect any data for its FDA-approved protocol—identified as a Device Exposure Registry (DER) study—as part of the PAS requirements in the 4.5 years since the conditional approval. Ocular Therapeutix’...
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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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    Data Integrity Q&A: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics. The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in thei...
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    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH). The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...