{"id":6677,"date":"2023-02-20T20:56:36","date_gmt":"2023-02-20T20:56:36","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=6677"},"modified":"2024-01-12T20:56:03","modified_gmt":"2024-01-12T20:56:03","slug":"fda-qsit-medical-device-manufacturer","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/fda-qsit-medical-device-manufacturer\/","title":{"rendered":"Understanding What Happens During a Medical Device QMS Inspection"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6677\" class=\"elementor elementor-6677\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6dd05cd3\" data-id=\"6dd05cd3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-6ea4084d\" data-id=\"6ea4084d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2023\/02\/20\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tFebruary 20, 2023\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/inspector-writing-on-clipboard_Resized1104W736H.jpg\" class=\"attachment-full size-full wp-image-2198\" alt=\"QSIT Audit\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>Unlike Regulatory Authorities in most other countries, the US Food and Drug Administration (FDA) relies on random inspections to keep medical device manufacturers honest.<\/strong><\/p><p>Random audits can occur at any time, and that means manufacturers must always remain in compliance with the FDA Quality System Regulation (QSR).<\/p><p>There are simply too many medical device manufacturers for FDA to inspect annually, so FDA prioritizes its limited inspection staff according to the risk posed by manufacturers ,their devices and if the company has had any product related problems in the recent past. Some companies get more attention than others.\u00a0<strong>In general, Class II and III manufacturers can expect an FDA visit every two years.<\/strong>\u00a0The risk-based approach means companies with new or existing Class III devices are the highest priority, especially those making implantable and life-supporting devices. Class II manufacturers (the bulk of the volume) are next in line, along with any companies that have recently introduced a device via the 510(k) process. Occasionally, FDA will inspect higher-risk Class I manufacturers. Companies that have had their hand slapped in the past tend to get frequent repeat visits, which are often unannounced. FDA can also conduct \u201cfor cause\u201d inspections \u2013 hopefully you\u2019re not reading this article to find out what that means.<\/p><p>If you have not yet had the pleasure of experiencing an FDA inspection, here\u2019s how it goes down.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6006e54b elementor-widget elementor-widget-heading\" data-id=\"6006e54b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Advance Notice of FDA Inspections and What Happens Next<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ce6da04 elementor-widget elementor-widget-text-editor\" data-id=\"2ce6da04\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p style=\"line-height: 18.0pt; background: white; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">Generally, FDA will notify US-based manufacturers at least 5 days before an inspection. Foreign companies typically get more advance notice so that travel and translator arrangements can be made. Before the inspection, FDA may request that you send them a copy of your quality system manual and management review procedures to facilitate the inspection. You are not required to send these documents, but refusing to do so might put the inspector in the frame of mind to think that you have something to hide.<\/span><\/p><p style=\"line-height: 18.0pt; background: white; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">When the FDA inspectors arrive (there may be more than one, depending on the size of your company), they will present their badge and ask to see the most senior management official. While you are allowed to write down their name and badge number, you may not photograph or copy their badge. They will then present a Form 482 \u201cNotice of Inspection\u201d as a formality and have an opening meeting to learn more about the structure of your company and products, followed by a facility tour.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Time to Get Down to Business<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p style=\"line-height: 18.0pt; background: white; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">The FDA inspection approach focuses on reviewing procedures and then examining records associated with them. To understand what they will cover and how, study the 108-page QSIT manual prepared to guide FDA field staff and share it with others who might be involved in the inspection. It dates from 1999 but is still in use today.<\/span><\/p><p style=\"line-height: 18.0pt; background: white; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">The inspection process focuses on four main subsystems (as shown in blue below) with the ultimate question being: Did the management team provide the necessary resources to establish and maintain an effective QMS? The other three subsystems are reviewed via links with the four main subsystems. All seven subsystems orbit around management controls<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-63257b3 elementor-widget elementor-widget-image\" data-id=\"63257b3\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"640\" height=\"355\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/The-QSIT-process-focuses-on-four-main-subsystems_.jpg\" class=\"attachment-large size-large wp-image-2205\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/The-QSIT-process-focuses-on-four-main-subsystems_.jpg 805w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/The-QSIT-process-focuses-on-four-main-subsystems_-300x166.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/The-QSIT-process-focuses-on-four-main-subsystems_-768x426.jpg 768w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f0f011 elementor-widget elementor-widget-heading\" data-id=\"0f0f011\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Three Levels of FDA Inspections<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08bb4a2 elementor-widget elementor-widget-text-editor\" data-id=\"08bb4a2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>If this is your first FDA audit, the inspectors will cover all four subsystems. During subsequent normal inspections, the inspectors will cover CAPA plus one additional subsystem. As explained in a 2019 draft guidance document from FDA, the\u00a0<a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=FDA-2019-D-0914-0001&amp;attachmentNumber=1&amp;contentType=pdf\">typical inspection<\/a>\u00a0can be expected to last 3-6 business days. FDA should tell you how many days they expect the inspection will last when it notifies you of the impending audit.\u00a0 Remember, the length of time may depend on what the FDA finds when onsite.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-59e67f3 elementor-widget elementor-widget-image\" data-id=\"59e67f3\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"640\" height=\"299\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/Three-Levels-of-FDA-QSIT-Inspections-1024x478.jpg\" class=\"attachment-large size-large wp-image-2203\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/Three-Levels-of-FDA-QSIT-Inspections-1024x478.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/Three-Levels-of-FDA-QSIT-Inspections-300x140.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/Three-Levels-of-FDA-QSIT-Inspections-768x358.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/Three-Levels-of-FDA-QSIT-Inspections.jpg 1440w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17b2a83c elementor-widget elementor-widget-heading\" data-id=\"17b2a83c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What the FDA Inspector Is Looking for During an Inspection<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fded163 elementor-widget elementor-widget-text-editor\" data-id=\"3fded163\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>The process is top down. It begins with a review of your procedures and then dives into a random sampling of associated records. (If you love stats and want to get into the nuts and bolts of how many samples FDA will review, you\u2019ll enjoy\u00a0 pages 103-107 of the manual.) The FDA inspectors don\u2019t have the authority to demand to see your \u00a0internal audit reports, supplier audit reports, or your management review meeting minutes. They can request them, but you it is up to the organization whether they are made available. This should be defined in an established procedure within the QMS. However, they will check to make sure you have these documents. While the inspection is quite methodical, as outlined in the table below, the inspectors may dig deeper if they find an area of concern. As they proceed through the inspection, they will point out Form 483 observations in real time. These are more serious areas of concerns than \u201cdiscussion items,\u201d which get documented in the final report but could later be elevated to observations. You can expect that the FDA inspectors will hold daily meetings with the management team to disclose what was discovered that day.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c1c628 elementor-widget elementor-widget-image\" data-id=\"3c1c628\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"640\" height=\"34\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-1024x55.jpg\" class=\"attachment-large size-large wp-image-2212\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-1024x55.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-300x16.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-768x42.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT.jpg 1126w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd0ae23 elementor-widget elementor-widget-image\" data-id=\"fd0ae23\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"640\" height=\"204\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Mgmt1-1024x326.jpg\" class=\"attachment-large size-large wp-image-2208\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Mgmt1-1024x326.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Mgmt1-300x95.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Mgmt1-768x244.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Mgmt1.jpg 1119w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eea1082 elementor-widget elementor-widget-image\" data-id=\"eea1082\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"640\" height=\"331\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Dsgn2-1024x529.jpg\" class=\"attachment-large size-large wp-image-2209\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Dsgn2-1024x529.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Dsgn2-300x155.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Dsgn2-768x397.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-Dsgn2.jpg 1118w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20fa314 elementor-widget elementor-widget-image\" data-id=\"20fa314\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"640\" height=\"486\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-CAPA3-1024x778.jpg\" class=\"attachment-large size-large wp-image-2210\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-CAPA3-1024x778.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-CAPA3-300x228.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-CAPA3-768x583.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-CAPA3.jpg 1126w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-088e33b elementor-widget elementor-widget-image\" data-id=\"088e33b\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"640\" height=\"201\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-PPC4-1024x322.jpg\" class=\"attachment-large size-large wp-image-2211\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-PPC4-1024x322.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-PPC4-300x94.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-PPC4-768x242.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/09\/QSIT-PPC4.jpg 1125w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4437ddb2 elementor-widget elementor-widget-heading\" data-id=\"4437ddb2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What Happens at the Conclusion of the FDA Inspection?<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a930c53 elementor-widget elementor-widget-text-editor\" data-id=\"6a930c53\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>At the conclusion of what is sure to be an exhausting and stressful week for you, the investigators will meet with management to review all observations and discussion points. The inspectors will give management an opportunity to defend or clarify their position and will document everything in an Establishment Inspection Report (EIR). The date and status of your inspection (but not the actual EIR) will be posted on the FDA website within a week. The most important field here is \u201cClassification,\u201d which is separated into three categories:<\/p><p>\u00a0<\/p><p><em><strong>NAI \u2013 No Action Indicated <\/strong>(inspection went well, this is what you hope to see)<\/em><\/p><p><em><strong>VAI \u2013 Voluntary Action Indicated <\/strong>(the inspectors found some problems; FDA expects the company to take corrective action)<\/em><\/p><p><em><strong>OAI \u2013 Official Action Indicated <\/strong>(the inspectors found serious issues; this means a 483 will likely be issued)<\/em><\/p><p>\u00a0<\/p><p>Of course, the outcome shouldn\u2019t be a surprise to you, as the FDA inspectors would have pointed out problems throughout the inspection and in daily meetings. You can request a copy of your EIR within 60 days. If things did not go so well, the inspectors may issue an FDA Form 483 \u00a0and you will have 15 days to respond. FDA could take things to the next level by issuing a Warning Letter, but this is increasingly rare. By the way, when the FDA investigator presents the 483, you are NOT required to sign it. If you do, that\u2019s an admission that everything in the report is accurate and true in a court of law&#8230;.if it comes to that. Again, whether you do or don\u2019t sign should be documented in a formal procedure in your QMS.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16fe8642 elementor-widget elementor-widget-heading\" data-id=\"16fe8642\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">More Ways to Prepare for Your Next Audit<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1812748d elementor-widget elementor-widget-text-editor\" data-id=\"1812748d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>If you made it this far, there\u2019s a good chance that you are heavily involved in FDA QSR and ISO 13485 compliance. If so, consider our in-depth\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/FDA-QSR-training-21cfr820\">training on ISO 13485 and FDA QSR<\/a>, or our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/lead-auditor-training-for-ISO-13485\">ISO 13485 lead auditor training<\/a>\u00a0class. Alternatively, ask us about having one of our skilled auditors conduct\u00a0<a href=\"https:\/\/www.orielstat.com\/practice\/quality-system-audit-services-training\">outsourced audits<\/a>\u00a0on your behalf.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-375d07a3 elementor-widget elementor-widget-shortcode\" data-id=\"375d07a3\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. Call<\/h6>\n    <\/div>\n    <div id=\"Bottom_icons1_DivOfficePhone\" class=\"row new_update_add\">\n<div class=\"col-lg-6 col-md-12 borderbottom\">\n <div class=\"block-text1\">\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/us-flag.jpg\">\n     <p>\n         <b>US Office<\/b>Washington DC<\/p>\n <\/div>\n <p>\n     <a href=\"tel:1.800.472.6477\">1.800.472.6477<\/a><\/p>\n<\/div>\n<div class=\"col-lg-6 col-md-12\">\n <div class=\"block-text1\">\n     <p>\n         <b>EU Office<\/b>Cork, Ireland<\/p>\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/eu-flag.jpg\" class=\"img-right-sec\">\n <\/div>\n <p>\n     <a href=\"tel:+353 21 212 8530\">+353 21 212 8530<\/a><\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element 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Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection Unlike Regulatory Authorities in most other countries, the US Food and Drug Administration (FDA) relies on random inspections to keep medical device manufacturers honest. Random audits can occur at any time, and that means manufacturers must always remain in compliance with the FDA [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2228,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[14,28],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"description\" content=\"Has the FDA scheduled an inspection of your facility? 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