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  • Feature ArticlesFeature Articles

    Recasting CAPA as a continuous improvement process

    This article summarizes a white paper developed by the Medical Device Innovation Consortium (MDIC) under the case-for-quality program. The white paper recasts the corrective and preventive action (CAPA) process as a continuous improvement process for driving higher product quality and improved patient safety.   Introduction Today’s CAPA process has become highly focused on compliance. This focus leaves manufacturers struggling to determine which issues require a stru...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
  • Regulatory NewsRegulatory News

    FDA Warns Three Device Companies From US, Germany and France, One Indian API Manufacturer

    The US Food and Drug Administration (FDA) this week released three warning letters sent to medical device manufacturers, including Florida-based UVLrx Therapeutics, Inc., Germany-based DRG Instruments GmbH and France-based ELITech Group SAS, as well as one to the Vapi, India-based active pharmaceutical ingredient (API) manufacturer Vital Laboratories. UVLrx Therapeutics The inspection conducted at UVLrx from 27 March 2017 to 4 April 2017 to assess a clinical study t...
  • Regulatory NewsRegulatory News

    FDA Form 483 Cites 14 Observations for Zimmer Biomet

    Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Detroit-based site with 14 observations. The 58-page, heavily-redacted Form 483 follows the site inspection from 12 September 2016 to 22 November 2016. The first observation – on sterilization validation and a “test that has not been adequately validated” – and the seven...
  • Regulatory NewsRegulatory News

    FDA Warns 14 International Medical Device Companies

    The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines. By far the most common issues cited by FDA were: Number of Citations Issue 11 Failure to establish and maintain adequate procedures for imple...
  • Regulatory NewsRegulatory News

    CDRH Increases Foreign Quality System Inspections

    Although the number of quality system surveillance inspections only rose slightly between 2013 and 2014 overall, the number of such inspections for foreign manufacturers increased by nearly 30%, according to new data released by the FDA’s Center for Devices and Radiological Health (CDRH). CDRH said the new numbers show that the agency, which previously upped its inspections of foreign generic drug manufacturers , has been working to increase inspections in foreign count...
  • Feature ArticlesFeature Articles

    Creating a Culture of Compliance

    In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis. This focus creates a culture that views compliance as a positive, critically important part of the business. In fact, a recent study sho...
  • Feature ArticlesFeature Articles

    Medical Device Corrective and Preventive Actions

    Medical device companies are required by law 1 to have corrective and preventive action (CAPA) procedures to identify, prevent and correct product quality nonconformities. The effectiveness of a CAPA procedure can make the difference between successfully resolving deficiencies and enduring recurring deficiencies that result in waste, inefficiency, customer dissatisfaction and, potentially, patient-related adverse events. An effective CAPA procedure protects the customer...
  • Rare Multi-Facility Warning Letter Slams Manufacturer, Says Concerns Extend to All Plants

    A Warning Letter sent by the US Food and Drug Administration (FDA) to generic manufacturing company Apotex, Inc. cites a number of "serious" current good manufacturing practice deficiencies found at two manufacturing sites maintained by the company-a rarity among FDA Warning Letters. The 21 February 2013 letter references a 13-24 August inspection of two Canada-based facilities operated by the company. Facility One: Toronto At the first facility, FDA claimed the compan...
  • Alleged Sterility Deficiencies Behind Warning Letter to Medical Device Company

    A warning letter to Atrium Medical Corporation , a new Hampshire-based medical device manufacturer, claims at least four of the company's products are adulterated as a consequence of poor manufacturing practices. The 11 October letter from the US Food and Drug Administration (FDA) cites a number of findings made during the course of an inspection made between 31 July and 7 September. Among the most troubling allegations made by FDA is the systematic failure of steril...