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  • Regulatory NewsRegulatory News

    FDA Flags 41,000 Adverse Event Reports Linked to Surgical Staplers, Staples

    The US Food and Drug Administration (FDA) sent a letter to health care providers Friday over a growing body of adverse events associated with surgical staplers and implantable staples.   The agency’s ongoing analysis of medical device reports (MDRs) found that it received more than 41,000 individual MDRs that describe adverse events associated with the use of surgical staplers and staples for internal use between 1 January 2011 and 31 March 2018.   These include 36...
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    FDA Warns Teva Subsidiary Over Quality Failures, CGMP Violations

    Teva Pharmaceuticals subsidiary Actavis Laboratories FL, Inc. received a warning letter last month from the US Food and Drug Administration (FDA) for quality unit concerns and inconsistencies with its laser-drilled tablet manufacturing processes, among other violations. Actavis Laboratories’ quality unit at the Davie, Florida-based site was found to have “failed to fulfill its duties and responsibilities,” the warning letter says, noting for example that the unit did no...
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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 Cites GMP, GLP Violations at Two Sites

    The US Food and Drug Administration (FDA) posted two warning letters on Monday that flagged a total of nine violations of good manufacturing practice (GMP) at California-based Total Thermal Imaging (TTI) and four violations of good laboratory practice (GLP) at an American Preclinical Services (APS) facility in Minneapolis. TTI’s warning letter comes after an FDA inspection of its website and brochures concluded that its Thermographic Business Package lacked the approv...
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    FDA Warns of Increased Risk of Death With Gout Medicine Uloric

    The US Food and Drug Administration (FDA) on Thursday said it has concluded there is an increased risk of death with Takeda’s Uloric (febuxostat) when compared to another gout medicine, allopurinol, and the agency added a boxed warning to Uloric. “This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric,” FDA said in a safety communication. When Ul...
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    Datascope Draws Second FDA Warning

    Getinge Group subsidiary Datascope failed to adequately conduct device design validation, establish procedures for corrective and preventive actions (CAPAs) and evaluate and select potential suppliers, according to a US Food and Drug Administration (FDA) warning letter. The warning letter was issued to the firm— acquired  by Getinge in 2008—on 6 February and made public Wednesday. It marks the second warning letter to the Getinge subsidiary. The first one was issued  l...
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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 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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    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...