Advisor 462

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

Korean device company’s CAPA procedures fail to impress FDA

Principal Author & Editor: Prof David Hutchinson Senior Contributor: Jane Baguley Production Editor/Writer: Sharon Jordan Senior Correspondents: Fabio Camarri, Mark Elsley, Hideki Fujiwara, Lisbeth Tofte Hemmingsen, Peter Marks, Stuart McCully, ColinWilsher Aim To provide news and information to allow clinical research and quality assurance professionals, trainers, regulators, academics and members of ethics committees to stay up to date with clinical research and good practice developments. Scope Executive summaries of key laws and guidelines relating to clinical research in the ICH regions. Summaries of relevant articles and information in other publications, press releases and information on the Internet. Information on: • changes in regulations, codes of practice, guidelines and new clinical research procedures • news from important meetings and conferences • ICH developments and progress • news, views and opinions about ICH GCP implementation • solutions to compliance-related problems • inspection findings and lessons to be learnt • clinical research methodology, statistical and legal issues • quality assurance issues and procedures • self- and independent audit practice • training courses, jobs and other opportunities. Sources of information • We gather news from correspondents and other sources around the world. • We gather intelligence from those actively involved in the regulatory process. • We review the major medical, clinical research and QA journals. • We search the web and regularly visit the websites of the major regulatory authorities in Europe, the USA and Japan, pharmaceutical industry and professional associations, major academic organisations and health associations. • Sources of information, current at the time of publication, are usually quoted at the end of each article. Published by: Brookwood Global (Canary Ltd), 5 Studley Court Mews, Chobham, Surrey GU24 8EB, UK Telephone: +44 1483 811383; Fax: +44 1483 812163 Email: info@brookwood-global.com; website © Canary Ltd 2020 All rights reserved. No part of this publication may be copied, transmitted, reproduced in any way without the written permission of the publisher. Disclaimer: Whilst we try to ensure that information published is correct, the Editors, Advisors or publishers accept no liability for losses or damages arising. You should always seek a second opinion before acting on any information provided.

The FDA has issued a warning letter to a South Korean medical device company detailing multiple deficiencies, including several relating to its corrective and preventive action (CAPA) procedures. The medical device company was initially inspected by the FDA in October 2015 and a first warning letter was issued in December 2016. A follow- up inspection took place in April 2019 and resulted in a second warning letter, which states that the device company had failed to adequately establish and maintain procedures for implementing CAPAs, as required by the federal regulations (21 CFR 820). The letter refers back to the original inspection, and indicates that the company’s CAPA procedures were inadequate as they had not fully investigated the root cause of all the previously identified inspection deficiencies. The deficiencies included findings relating to the design validation procedure, medical device reporting procedure, complaint handling procedure and device history record procedure, and other quality system deficiencies. These were all documented in an FDA Form 483 issued on 15 October 2015. The company responded that it had revised its guidelines in line with the FDA’s requirements for CAPA procedures, and provided a revised CAPA report for the agency’s input and evaluation. Other CAPA reports generated to address the observations from the second inspection were also provided, along with a CAPA Report for Observation from the October 2015 inspection, which included information on verification and validation performed for those particular CAPA procedures. However, in the second warning letter the FDA explained that it found the company’s response to be inadequate. Specifically, the company did not • provide evidence that it had investigated all the deficiencies identified in 2015 and conducted verification or validation to ensure that any actions taken were effective • address any plans to conduct a retrospective analysis of other potential non-conformities associated with each respective observation from the previous inspection. In response to these and several other findings described in the warning letter, the FDA has taken steps to prevent the company’s medical devices from entering the USA. Source:

Take the chance to top up your skills online

Look at our wide range of short ‘1-hour’ courses in GCP (sponsors and investigators), pharmacovigilance, data management, good clinical practice for clinical trial sample management, data protection (GDPR) and non-interventional study design and management. Visit our e-brochure, see clips and buy online. https://brookwood-global.com/Books/Online-Training-Brochure/

Design: LIMA Graphics, Fleet, Hampshire, UK Print: Surrey Litho, Great Bookham, Surrey, UK

page 8

Issue 462, 2020 www.brookwood-global.com