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  • Regulatory NewsRegulatory News

    Smiths Medical warned by FDA for multiple violations

    The US Food and Drug Administration (FDA) slapped Smiths Medical in Minneapolis, MN with a warning letter for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation processes, and lax corrective and preventative actions (CAPA) procedures. The company makes blood warmers and infusion pumps.   The warning letter was issued on 1 October and posted on 23 November. It follows a recent recall of the company’s ...
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    Wound dressing firm warned for design, environmental control issues

    An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems including a lack of medical device reporting procedures, design control issues, and lack of document and environmental control, among others.   CellEra LLC, which distributes wound dressings with drugs such as silver, petrolatum and collagen, received the 20 October warnin...
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    FDA official: Growing number of enforcement actions stem from inspection alternatives

    Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and import alerts issued in fiscal year 2021 were based on product sampling and reviewing firms’ written responses to record requests, not from traditional onsite inspections.   So asserted Francis Godwin, director of Office of Manufacturing Quality (OMQ) in FDA’s Center for Drug Evaluation and Research (CDER) at a compliance and enforcement update at a 26 October...
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    FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires

    Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administration (FDA) to issue three warning letters for good manufacturing practice (GMP) violations to an over the counter drug manufacturer, a finished drug manufacturer and an API manufacturer in the US.   The recipients of the warning letters, w...
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    Three foreign OTC firms slapped with warning letters for GMP testing violations

    Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one led the US Food and Drug Administration (FDA) to issue three warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.   The recipients of the warning letters, which were all issued in mid-September, include Laboratorio Pharma International in Tegucigalpa, Honduras, a manufacturer of antibiotics and ...
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    Kaleido warned; FDA not persuaded by 'medical food' claim

    The US Food and Drug Administration (FDA) recently issued a warning letter to Kaleido Biosciences for administering an investigational new COVID-19 treatment to patients without obtaining an investigational new drug (IND) application.   The company argued that the product under investigation was a food and not a drug, and therefore not subject to IND filing requirements. Yet the agency disagreed, saying that the endpoints used in the clinical trials went beyond ‘diet...
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    FDA says Turkish OTC maker’s testing program earns failing grades

    The US Food and Drug Administration (FDA) criticized a Turkish manufacturer of over-the-counter drugs for failing to test incoming ingredients and to test products before releasing them to the market in a recent warning letter . The company was also warned for its lax approach to stability testing.   The 13 May letter to Istanbul-based Gulsah Uretim Kozmetik Sanayi Anonim Sirketi follows up on FDA’s review of a 23 April response to request for records. The firm is the...
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    JAK inhibitors' CV, cancer risks merit expanded boxed warning

    The boxed warnings for several members of a class of drugs used to treat a number of inflammatory conditions must be revised to reflect the increased risk of cancer, serious cardiovascular problems and death seen in people taking the drugs, according to a new drug safety communication from the US Food and Drug Administration (FDA).   The revisions come after safety data from a randomized clinical trial of Pfizer’s Xeljanz (tofacitinib) and is extended release formulati...
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    Antifreeze and APIs don't mix, FDA tells Syntec

    The US Food and Drug Administration has warned New York-based pharmaceutical manufacturer Syntec for a litany of good manufacturing practice (GMP) problems. The agency says that issues related to how the firm handles active pharmaceutical ingredients (API) compromise the safety of the drugs produced at the site.   Among the problems found by FDA at the firm’s site in Farmingdale, NY, were inadequate contamination safeguards, as well as lax cleaning and testing proced...
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    FDA to Amazon: Stop shipping products that contain undisclosed drugs

    The mammoth online retailer Amazon received an untitled letter from The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) identifying 26 sexual enhancement and weight loss products that contain “undeclared” and “potentially harmful” drug ingredients, according to FDA’s testing of the products.   In this letter — not the first correspondence the agency has had with Amazon on the matter —the firm was called out for marketing unapprove...
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    Warning letter: FDA blasts Innova for falsifying data, GMP violations

    Editor's note: This article has been updated to include a statement from Innova. The US Food and Drug Administration issued a warning letter on 10 June to Innova Medical Group for distributing unauthorized SARS-CoV-2 rapid antigen tests and "false or misleading" information in the tests’ labeling.   The warning letter comes after FDA inspected two of the firm’s facilities in Pasadena and Brea, CA over the course of several weeks in March and April.   FDA also ...
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    FDA’s document-based inspections prompt warning letters for GMP violations

    The US Food and Drug Administration (FDA) on 13 April warned South American active pharmaceutical ingredient (API) manufacturer Proquimes SA Productos Quimicos Especializados SA for a multitude of good manufacturing practice (GMP) violations. The letter joins three others the agency has issued since the beginning of the year that are based solely on a records review and not onsite inspections.   The warning letters signal the agency’s increasing reliance on a review of...