{"id":159,"date":"2019-08-27T11:24:04","date_gmt":"2019-08-27T15:24:04","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=159"},"modified":"2019-08-27T11:24:04","modified_gmt":"2019-08-27T15:24:04","slug":"otc-personal-products-manufacturer-cited-by-fda-for-various-regulatory-violations","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/08\/27\/otc-personal-products-manufacturer-cited-by-fda-for-various-regulatory-violations\/","title":{"rendered":"OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations"},"content":{"rendered":"<p>On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a\u00a0<a title=\"Warning Letter to NingBo Huize Commodity Co., Ltd.\" href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/ningbo-huize-commodity-co-ltd-581345-08022019?utm_campaign=082019_PR_FDA%20warns%20company%20for%20putting%20consumers%20at%20risk&amp;utm_medium=email&amp;utm_source=Eloqua\" target=\"_blank\" rel=\"noopener noreferrer\">warning letter<\/a>\u00a0to an over-the-counter drug manufacturer citing \u201csignificant\u201d violations of current good manufacturing practice (CGMP) and also issued a\u00a0<a title=\"FDA warns company for putting consumers at risk with drug manufacturing data integrity violations\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-warns-company-putting-consumers-risk-drug-manufacturing-data-integrity-violations\" target=\"_blank\" rel=\"noopener noreferrer\">news release<\/a>\u00a0in connection with this letter. The letter was sent to NingBo Huize Commodity Co., Ltd., a China-based manufacturer of health and beauty products such as sunscreen lotion, shampoo, hand sanitizer and lip balm, following FDA\u2019s inspection of the facility in March 2019. In particular, the warning letter, and concurrent press release and import alert, show that FDA continues to have significant concerns related to data integrity and will harshly sanction companies that falsify data.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/otc_personal_products_manufacturer_cited_fda_various_regulatory_violations_0819.html\">View the full <em>Alert<\/em> on the Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a\u00a0warning letter\u00a0to an over-the-counter drug manufacturer citing \u201csignificant\u201d violations of current good manufacturing practice (CGMP) and also issued a\u00a0news release\u00a0in connection with this letter. The letter was sent to NingBo Huize Commodity Co., Ltd., a China-based manufacturer of &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/08\/27\/otc-personal-products-manufacturer-cited-by-fda-for-various-regulatory-violations\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[344,29,209,388,389,390,391,119,172],"ppma_author":[521],"class_list":["post-159","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-data-integrity","tag-fda","tag-frederick-ball","tag-justin-stern","tag-otc","tag-over-the-counter","tag-regulatory-violation","tag-rick-ball","tag-warning-letter"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","author_category":"1","last_name":"Sullivan","first_name":"Margaret","job_title":"","user_url":"http:\/\/www.duanemorris.com","description":"<a href=\"http:\/\/www.duanemorris.com\">Visit the Duane Morris website.<\/a>"}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/159","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=159"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/159\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=159"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=159"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=159"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=159"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}