{"id":9904,"date":"2019-06-28T13:56:37","date_gmt":"2019-06-28T11:56:37","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9904"},"modified":"2019-06-28T13:56:37","modified_gmt":"2019-06-28T11:56:37","slug":"fda-issues-the-first-warning-letter-for-udi-violations","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2019\/06\/28\/fda-issues-the-first-warning-letter-for-udi-violations\/","title":{"rendered":"FDA issues the first warning letter for UDI violations"},"content":{"rendered":"\n<p>After conducting an inspection of Zeller Power Products\u2019 medical device operations, the FDA concluded that the firm was not compliant with the US GMP requirements under 21 CFR 820 Quality System Regulations.  <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/06\/USA_warning_letter_UDI-1024x536.png\" alt=\"\" class=\"wp-image-9899\"\/><figcaption><em>FDA issues the first warning letter for UDI violations<\/em><\/figcaption><\/figure>\n\n\n\n<p>On May 9, 2019, a <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/zeller-power-products-llc-570909-05092019?utm_source=CDRHTwitterD\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Warning Letter was issued by the FDA<\/a> because the specific violations noted in the FDA Form 483 \/ Inspectional Observations issued at the close of the inspection on November 9, 2018 were not addressed properly by the manufacturer.<\/p>\n\n\n\n<p>The violations\nincluded, but were not limited to:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Failure to ensure that the label of every medical device bears a <strong>Unique Device Identifier <\/strong>(UDI) that meets the requirements of 21 CFR 801 Subpart B and 21 CFR 830, as required by 21 CFR 801.20(a). Class III devices manufactured and labeled after September 24, 2014, <strong>must bear an UDI<\/strong>, unless an exception or alternative applies.<\/li><li>Failure to provide the required information to <a href=\"https:\/\/accessgudid.nlm.nih.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Global Unique Device Identification Database (GUDID)<\/a> as required by 21 CFR 830.300(a). Labelers of devices <strong>required to bear an UDI<\/strong> are <strong>required to submit specific data<\/strong> pertaining to these devices to FDA\u2019s GUDID on or before September 24, 2014.<\/li><\/ul>\n\n\n\n<p>Zeller Power Products, LLC was urged to\ninvestigate and determine the causes of the violations and take prompt actions\nto correct them, thus bringing their products into compliance.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>After conducting an inspection of Zeller Power Products\u2019 medical device operations, the FDA concluded that the firm was not compliant with  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[23],"tags":[],"class_list":["post-9904","post","type-post","status-publish","format-standard","hentry","category-us-agent"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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