{"id":1183,"date":"2026-02-13T13:10:14","date_gmt":"2026-02-13T13:10:14","guid":{"rendered":"https:\/\/hirekhan.com\/blog\/?p=1183"},"modified":"2026-02-13T13:10:17","modified_gmt":"2026-02-13T13:10:17","slug":"us-fda-records-access-under-mocra-what-cosmetic-companies-must-maintain-and-provide","status":"publish","type":"post","link":"https:\/\/hirekhan.com\/blog\/2026\/02\/13\/us-fda-records-access-under-mocra-what-cosmetic-companies-must-maintain-and-provide\/","title":{"rendered":"US FDA Records Access Under MoCRA: What Cosmetic Companies Must Maintain and Provide"},"content":{"rendered":"\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/eu-images.contentstack.com\/v3\/assets\/blt09e5e63517a16184\/blt66f504d79e5ed853\/67317b83072cb372dfd50239\/cosmetic-label-rules-canva-feature.png?width=1280&amp;auto=webp&amp;quality=80&amp;disable=upscale\" alt=\"Mandatory cosmetic recall authority list, Mandatory cosmetic recall authority 2022, Cosmetic recall 2025, Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA cosmetic regulations 2025, MoCRA cosmetics, What is MoCRA, FDA MoCRA, Does the FDA have the authority to mandate a recall?, What is a MoCRA in cosmetics?, Who is the responsible person under the FDA MoCRA?, Is it mandatory for a company to recall a product?, What are the 3 types of FDA recalls?, What is the FSMA recall authority?, What is the purpose of FSMA?, What is Section 27 of the Fssai Act?, What is the difference between a mandatory recall and a voluntary recall?, FDA records access MoCRA, US FDA cosmetic records, MoCRA compliance cosmetics, cosmetic recordkeeping, safety substantiation records, adverse event records cosmetics, cosmetic regulatory compliance, US FDA consultancy, XPRO America\"\/><\/a><\/figure>\n\n\n\n<p>The <strong>Modernization of Cosmetics Regulation Act (MoCRA)<\/strong> introduced a major shift in how cosmetic products are regulated in the United States. One of the most impactful changes is the expanded <strong>US FDA authority to access records<\/strong> related to cosmetic manufacturing, safety, and distribution.<\/p>\n\n\n\n<p>Under MoCRA, cosmetic companies are no longer expected only to maintain internal documentation\u2014they must also be prepared to provide specific records to the US FDA upon request. This change significantly strengthens regulatory oversight and places greater accountability on manufacturers, brand owners, private labelers, and importers.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">XPRO America<\/a> is a professional <strong>US FDA Consultancy<\/strong> that assists cosmetic companies in establishing compliant recordkeeping systems and preparing for US FDA records access under MoCRA.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Why US FDA Records Access Was Expanded Under MoCRA<\/a><\/h2>\n\n\n\n<p>Before MoCRA, the US FDA had limited authority to review cosmetic company records unless a product was suspected of causing serious harm. MoCRA expanded this authority to allow the US FDA to request and review records more broadly.<\/p>\n\n\n\n<p>The goals of expanded records access include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Improving product traceability<\/li>\n\n\n\n<li>Strengthening safety oversight<\/li>\n\n\n\n<li>Supporting faster enforcement actions<\/li>\n\n\n\n<li>Enhancing consumer protection<\/li>\n\n\n\n<li>Increasing regulatory transparency<\/li>\n<\/ul>\n\n\n\n<p>Records access ensures that cosmetic companies can demonstrate compliance, not merely claim it.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">When US FDA Can Request Cosmetic Records<\/a><\/h2>\n\n\n\n<p>Under MoCRA, the US FDA may request records when it has a reasonable belief that a cosmetic product or ingredient:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Is adulterated or misbranded, and<\/li>\n\n\n\n<li>Presents a threat of serious adverse health consequences or death<\/li>\n<\/ul>\n\n\n\n<p>In certain circumstances, the US FDA may also request records during inspections or investigations related to compliance verification.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Who Must Provide Records<\/a><\/h2>\n\n\n\n<p>The obligation to provide records primarily falls on the <strong>Responsible Person<\/strong> and, where applicable, the manufacturing or processing facility.<\/p>\n\n\n\n<p>This includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Brand owners<\/li>\n\n\n\n<li>Manufacturers<\/li>\n\n\n\n<li>Private labelers<\/li>\n\n\n\n<li>Distributors whose name appears on the product label<\/li>\n<\/ul>\n\n\n\n<p>Foreign companies selling cosmetics in the United States must also comply with records access requirements.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Types of Records Subject to US FDA Access<\/a><\/h2>\n\n\n\n<p>MoCRA authorizes the US FDA to access a wide range of cosmetic-related records, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Product formulation records<\/li>\n\n\n\n<li>Ingredient specifications<\/li>\n\n\n\n<li>Safety substantiation documentation<\/li>\n\n\n\n<li>Adverse event reports<\/li>\n\n\n\n<li>Manufacturing and processing records<\/li>\n\n\n\n<li>Quality control and testing data<\/li>\n\n\n\n<li>Distribution records<\/li>\n<\/ul>\n\n\n\n<p>These records must be accurate, complete, and readily retrievable.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Safety Substantiation Records<\/a><\/h2>\n\n\n\n<p>Cosmetic companies must maintain adequate safety substantiation demonstrating that each product is safe for its intended use.<\/p>\n\n\n\n<p>Safety substantiation records may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Toxicological risk assessments<\/li>\n\n\n\n<li>Ingredient safety evaluations<\/li>\n\n\n\n<li>Product testing results<\/li>\n\n\n\n<li>Scientific literature reviews<\/li>\n<\/ul>\n\n\n\n<p>These documents are among the most commonly requested records.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Adverse Event Records<\/a><\/h2>\n\n\n\n<p>Companies must maintain records of all adverse events, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Serious adverse events<\/li>\n\n\n\n<li>Non-serious adverse events<\/li>\n\n\n\n<li>Follow-up investigations<\/li>\n\n\n\n<li>Correspondence<\/li>\n<\/ul>\n\n\n\n<p>Records must be retained for <strong>six years<\/strong> and be accessible for US FDA review.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Manufacturing and GMP Records<\/a><\/h2>\n\n\n\n<p>MoCRA supports US FDA authority to review records related to manufacturing conditions and quality systems, such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Batch production records<\/li>\n\n\n\n<li>Cleaning and sanitation logs<\/li>\n\n\n\n<li>Equipment maintenance logs<\/li>\n\n\n\n<li>Supplier qualification records<\/li>\n\n\n\n<li>Training records<\/li>\n<\/ul>\n\n\n\n<p>These records help verify compliance with good manufacturing practices.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Distribution and Traceability Records<\/a><\/h2>\n\n\n\n<p>US FDA may request records showing:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Where products were distributed<\/li>\n\n\n\n<li>Lot or batch identification<\/li>\n\n\n\n<li>Quantity released<\/li>\n\n\n\n<li>Recall-related traceability<\/li>\n<\/ul>\n\n\n\n<p>Strong traceability systems support rapid response in recall situations.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Format and Accessibility of Records<\/a><\/h2>\n\n\n\n<p>Records must be:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Legible<\/li>\n\n\n\n<li>Organized<\/li>\n\n\n\n<li>Maintained in English or readily translatable<\/li>\n\n\n\n<li>Accessible within a reasonable timeframe<\/li>\n<\/ul>\n\n\n\n<p>Electronic records are acceptable if properly controlled and secure.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Consequences of Failing to Provide Records<\/a><\/h2>\n\n\n\n<p>Failure to provide requested records may result in:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>US FDA enforcement actions<\/li>\n\n\n\n<li>Warning letters<\/li>\n\n\n\n<li>Mandatory recalls<\/li>\n\n\n\n<li>Import alerts<\/li>\n\n\n\n<li>Product seizure<\/li>\n<\/ul>\n\n\n\n<p>Inability to produce records may also be interpreted as evidence of non-compliance.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Best Practices for MoCRA Recordkeeping Compliance<\/a><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Establish written recordkeeping SOPs<\/li>\n\n\n\n<li>Maintain centralized document repositories<\/li>\n\n\n\n<li>Assign record ownership responsibilities<\/li>\n\n\n\n<li>Conduct periodic internal audits<\/li>\n\n\n\n<li>Ensure alignment between labels, formulations, and records<\/li>\n\n\n\n<li>Work with an experienced US FDA Consultancy<\/li>\n<\/ul>\n\n\n\n<p>XPRO America helps implement these best practices.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">How XPRO America Supports US FDA Records Access Compliance<\/a><\/h2>\n\n\n\n<p>XPRO America operates as a trusted <strong>US FDA Consultancy<\/strong> offering:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Recordkeeping system design<\/li>\n\n\n\n<li>Safety substantiation documentation<\/li>\n\n\n\n<li>Adverse event record management<\/li>\n\n\n\n<li>GMP documentation support<\/li>\n\n\n\n<li>Compliance audits<\/li>\n\n\n\n<li>Inspection readiness programs<\/li>\n\n\n\n<li>Regulatory correspondence handling<\/li>\n<\/ul>\n\n\n\n<p>For professional support with MoCRA records access compliance, contact <strong><a>support@xproamerica.com<\/a><\/strong>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.xproamerica.com\/sales-lead\/index.php\" target=\"_blank\" rel=\"noopener\">Final Thoughts<\/a><\/h2>\n\n\n\n<p>US FDA records access under MoCRA represents a fundamental shift toward stronger cosmetic oversight. Cosmetic companies must move beyond minimal documentation and establish robust, well-organized recordkeeping systems.<\/p>\n\n\n\n<p>With expert guidance from XPRO America, cosmetic brands can confidently meet US FDA records access requirements and demonstrate full regulatory compliance.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Modernization of Cosmetics Regulation Act (MoCRA) introduced a major shift in how cosmetic products are regulated in the United States. One of the most impactful changes is the expanded US FDA authority to access records related to cosmetic manufacturing, safety, and distribution. Under MoCRA, cosmetic companies are no longer expected only to maintain internal [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[3444,3432,3445,3285,3434,185,40,3442,3438,3431,3430,3382,3245,3268,3446,3265,3443,3439,3435,3433,3440,3441,3436,3437,3399,70],"class_list":["post-1183","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-adverse-event-records-cosmetics","tag-cosmetic-recall-2025","tag-cosmetic-recordkeeping","tag-cosmetic-regulatory-compliance","tag-does-the-fda-have-the-authority-to-mandate-a-recall","tag-fda-cosmetic-regulations-2025","tag-fda-mocra","tag-fda-records-access-mocra","tag-is-it-mandatory-for-a-company-to-recall-a-product","tag-mandatory-cosmetic-recall-authority-2022","tag-mandatory-cosmetic-recall-authority-list","tag-mocra-compliance-cosmetics","tag-mocra-cosmetics","tag-modernization-of-cosmetics-regulation-act-of-2022-mocra","tag-safety-substantiation-records","tag-us-fda-consultancy","tag-us-fda-cosmetic-records","tag-what-are-the-3-types-of-fda-recalls","tag-what-is-a-mocra-in-cosmetics","tag-what-is-mocra-2","tag-what-is-section-27-of-the-fssai-act","tag-what-is-the-difference-between-a-mandatory-recall-and-a-voluntary-recall","tag-what-is-the-fsma-recall-authority","tag-what-is-the-purpose-of-fsma","tag-who-is-the-responsible-person-under-the-fda-mocra","tag-xpro-america"],"_links":{"self":[{"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/posts\/1183","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/comments?post=1183"}],"version-history":[{"count":1,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/posts\/1183\/revisions"}],"predecessor-version":[{"id":1184,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/posts\/1183\/revisions\/1184"}],"wp:attachment":[{"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/media?parent=1183"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/categories?post=1183"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hirekhan.com\/blog\/wp-json\/wp\/v2\/tags?post=1183"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}