White Plains, NY, September 10, 2026 \u2014 ConsumerLab.com has obtained results of the FDA\u2019s inspections in Fiscal Year 2025 (October 1, 2024 – September 30, 2025) of 800 dietary supplement manufacturing facilities in the U.S. and abroad, showing that nearly half \u2013 49.1% — received letters indicating noncompliance with current Good Manufacturing Practices (cGMPs).<\/p>\n
Manufacturers are required by law to follow cGMPs. Only a small fraction of facilities are inspected by the FDA each year. ConsumerLab.com received the results under the Freedom of Information Act.<\/p>\n
The results for each manufacturer are posted on the ConsumerLab.com website<\/a> (member sign-in required).<\/p>\n The results are slightly better than when ConsumerLab last requested audit results five years ago for Fiscal Year 2020, when 51% of sites received noncompliance letters, also known as Form 483 letters, although the selection of facilities was different.<\/p>\n Most of the inspections, 720 out of 800, in FY 2025 occurred in the U.S. Among U.S. facilities that were inspected, 47.6% received citations of noncompliance, although this was an improvement over 52% in FY 2020 and 61.5% in FY 2015.<\/p>\n Eighty inspections occurred in countries outside the U.S. Among these, 72.5% received noncompliance citations — much worse than in the U.S. and much higher than 41.7% in 2020.<\/p>\n The countries with the most inspections after the U.S. were Canada and the Republic of Korea. In each, 5 out of 11 facilities (45.5%) received citations of noncompliance.<\/p>\n In Germany, only 2 of 8 (25%) of facilities received citations, which was similar to Australia where only 1 of 4 was cited. The opposite was true in China, where 5 of 7 (71.4%) received citations and in Mexico where 2 of 3 (66.7%) received citations.<\/p>\n Worst performing countries:<\/p>\n Countries that fared worst — where all inspected facilities received citations of noncompliance — were India, where all 10 of 10 inspected facilities received citations, as well as Japan (5 of 5), Brazil (3 of 3), New Zealand (2 of 2), Peru (2 of 2), and Switzerland (2 of 2). Brazil has continually shown problems, with both facilities inspected in 2020 receiving citations, as well as all 5 facilities inspected in FY15.<\/p>\n The FDA did not provide details on the types and number of infractions, but, in 2020, it informed ConsumerLab of a median of 4 infractions at facilities that received notices, of which the most common infractions were:<\/p>\n not establishing product specifications for the identity, purity, strength, and\/or composition of the finished dietary supplement ConsumerLab finds that about one in five supplements in the U.S. and Canada that it tests in its product reviews<\/a> do not meet quality parameters. Its testing tends to focus on more popular and established brands, guided by an annual survey<\/a> of its readers\u2019 interests. Consequently, its overall findings tend to be better than those published by researchers focusing on general market or lesser-known brands.<\/p>\n The Form FDA 483 letters do not represent the FDA\u2019s final determination regarding compliance. Companies may respond to the observations in the letters. If responses are insufficient, the FDA may issue a Warning Letter. ConsumerLab.com regularly posts these Warning Letters on the Recalls and Warnings page<\/a> and in its free newsletter<\/a>. One can also look up specific Form 483s in the Office of Inspections and Investigations FOIA Electronic Reading Room<\/a>.<\/p>\n \u2014 END \u2014\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"White Plains, NY, September 10, 2026 \u2014 ConsumerLab.com has obtained results of the FDA\u2019s inspections in Fiscal Year…\n","protected":false},"author":2,"featured_media":888493,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[64,63,137,532],"class_list":["post-888492","post","type-post","status-publish","format-standard","has-post-thumbnail","category-nutrition","tag-au","tag-australia","tag-health","tag-nutrition"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/888492","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=888492"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/888492\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/888493"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=888492"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=888492"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=888492"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nnot establishing or following written procedures for quality control operations
\nnot producing batch records which include the complete information relating to the production and control of each batch<\/p>\n