![]() In the audit results shown below by manufacturing facility name and location, those that passed inspection without a citation are highlighted in green. regularly posts these Warning Letters on the Recalls and Warnings page and in its free newsletter. If responses are insufficient, the FDA may issue a Warning Letter. Companies may respond to the observations in the letters. The Form FDA 483 letters do not represent the FDA's final determination regarding compliance. Its testing tends to focus on more popular and established brands, guided by an annual survey of its readers' interests. and Canada that it tests in its product reviews do not meet quality parameters. People may also be surprised that four out of five facilities were noncompliant in Germany, where many herbal supplements have drug status, although our own tests have also shown issues with some products from Germany." Overall, ConsumerLab finds that about one in five supplements in the U.S. is doing no better than China based on this limited sampling. Cooperman added, "Consumers often express concern about supplement ingredients from China, but the U.S. "Although an improvement over past years, the most recent FDA audits show that, overall, dietary supplement manufacturers need to do a lot better," commented Tod Cooperman, M.D., the founder and president of ConsumerLab, which has been testing and reporting the quality of dietary supplements in the U.S. There were no inspections in India in 2019, in contrast to FY16 when 9 of 11 facilities, or 81.8%, received citations. Both facilities inspected in Brazil received citations, consistent with Brazil having the worst record in FY15 when all 5 inspected facilities received citations. ![]() In contrast, none of the 3 facilities in Sweden received citations, while 2 of 3 in Mexico and Taiwan did, and 1 of 3 in Hungary, Japan, and Korea did. was China, where 3 out of 6 (50%) received citations of noncompliance (down from 71.4% in FY16), followed by Germany where all 4 out of 4 (100%) of inspected facilities received citations of noncompliance. The country with the most inspections after the U.S. Among these, 41.7% received noncompliance citations which, overall, is better than in the U.S. Sixty inspections occurred in countries outside the U.S., which is down from 74 in FY16. facilities that were inspected, 52% received citations of noncompliance, although this was an improvement from 61.5% in FY 2015. Most of the inspections, 538 out of 598, occurred in the U.S., which is up from 509 in FY16.
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