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. not producing batch records which include the complete information relating to the production and control of each batch (15.08%).not establishing or following written procedures for quality control operations (21.64%).not establishing product specifications for the identity, purity, strength, and/or composition of the finished dietary supplement (25.25%).Although specific infractions found at each facility were not disclosed, the most common infractions, each observed at more than 15% of noncompliant facilities, were: The FDA noted an average of 2.55 infractions and a median of 4 infractions at facilities which received notices. The figure fell to 65% in FY13, 62% in FY14, 58.2% in FY15, and back up to 62% in FY16 - the last time ConsumerLab had requested audit results. In FY12, 70% of dietary supplement firms inspected received a letter of noncompliance. There has been modest but steady improvement in GMP compliance rates in recent years. The results are shown in the table below by manufacturing facility name and location. received the results under the Freedom of Information Act. Only a small fraction of facilities are inspected by the FDA each year. Manufacturers are required by law to follow cGMPs. and abroad, showing that most - 51% - received letters indicating noncompliance with current Good Manufacturing Practices (cGMPs). has obtained results of the FDA's inspections in Fiscal Year 2019 (OctoSeptember 30, 2019) of 598 dietary supplement manufacturing facilities in the U.S.