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Posted March 30, 2015

FDA Finds Problems at 62% of Supplement Manufacturing Sites in U.S. and Abroad

ConsumerLab.com has obtained results of the FDA's inspections in 2014 of 483 dietary supplement manufacturing facilities, showing that most -- 62% -- received letters indicating noncompliance with current Good Manufacturing Practices (cGMPs). Manufacturers are required by law to follow cGMPs, but only a small fraction of facilities are inspected by the FDA each year. The results, by manufacturer, are posted on the ConsumerLab.com website (member sign-in required) and include results for manufacturers in the U.S. and abroad, listed by country. Manufacturers which passed inspection without a citation are highlighted in green, while those receiving a letter of noncompliance, known as a Form FDA 483, are highlighted in red.

ConsumerLab.com received the results on March 29, 2015 under the Freedom of Information Act and expects to report these results annually.

The FDA noted an average of 6 infractions at facilities which received notices. Although specific infractions found at each facility were not disclosed, the most common infractions -- observed at nearly 20% of noncompliant facilities, were:

  • not conducting at least one appropriate test or examination to verify the identity of a dietary ingredient and/or
  • not establishing product specifications for the identity, purity, strength, and/or composition of the finished dietary supplement

Among 483 sites inspected around the world, 62% received citations of noncompliance. Most of the inspections (255) occurred in the U.S., where, also, 62% received citations. The country with the most inspections after the U.S. was China, where 16 facilities were inspected. Results in China were somewhat better than in the U.S., with 9 (56%), receiving citations of noncompliance.

Among countries in which at least four inspections were performed, the percentages of facilities which received noncompliance letters were, from best to worst, 0% in Hong Kong, 33% in Switzerland, 43% in Japan, 75% in Mexico, 78% in India, 80% in Spain, and 88% in South Korea.

The Form FDA 483 letters do not represent the FDA's 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 and in its free newsletter.

Some of these findings were reported in a March 21 article in Natural Product Insider which noted "a modest improvement in cGMP compliance rates in recent years. In FY12, 70 percent of dietary supplement firms inspected received a 483. The figure fell to 65 percent in FY13."