Recalls and Warnings
(Date Posted: 3/17/2017)
|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 2016 of 583 dietary supplement manufacturing facilities, showing that most -- 362 (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 for each manufacturer are posted on the ConsumerLab.com website (member sign-in required).
ConsumerLab.com received the results under the Freedom of Information Act. Until 2016 there had been a slow but steady improvement in cGMP compliance rates: In fiscal year 2012 (ending 9/30/12), 70 percent of dietary supplement firms inspected received a letter of noncompliance. The figure fell to 65 percent in FY13, 62% in FY14, and 58.2% in FY15.
The median number of infractions at facilities which received notices rose to 4 from 2 in FY15, although this is still significantly lower than in FY14, when the median was 6 infractions. Although specific infractions found at each facility were not disclosed, the most common infractions, each observed at more than 10% of noncompliant facilities, were:
The vast majority of the inspections (509) occurred in the U.S., which was nearly double the number inspected in FY15. In the U.S., 61.5% of inspected facilities received citations of noncompliance. The country with the most inspections after the U.S. was China, where 10 out of 14 (71.4%) received citations, followed by India, where 9 out of 11 (81.8%) received citations, and the U.K., where 8 out of 11 (72.7%) received citations.
- not establishing product specifications for the identity, purity, strength, and/or composition of the finished dietary supplement
- not establishing or following written procedures for quality control
- not conducting at least one appropriate test or examination to verify the identity of a dietary ingredient and/or
- not preparing or following a written master manufacturing record for each batch
- not producing records which included the complete information relating to the production and control of each batch
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.
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For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.