FDA Supplement GMP Crosshairs More Frequently On Smaller Firms
This article was originally published in The Rose Sheet
GMP violation warnings to three small dietary supplement firms in late March reflect a “thoughtful shift” by FDA toward inspections of smaller firms, says UNPA President Loren Israelsen. With the supplement GMP final rule past its 10-year anniversary, firms should be meeting their requirements.
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FDA Office of Regulatory Affairs warned Nature Essence Small Molecule Co. in Lexington, KY, and Warner Herb Co. in Crossville, TN, both single-facility businesses. They likely appeared on FDA radar as it moves from inspecting larger supplement manufacturers for compliance with the 2007 GMP final rule to also reaching small firms.
Contract manufacturer Nutritional Engineering was warned on Sept. 29, 2017, about GMP violations and misbranding problems found during an inspection in April and May. Liberty, Texas, own-labeler Carol Bond Health Foods was warned March 9 following a September inspection of its facility and a November review of its website.
FDA publishes good manufacturing practices guidance for small businesses making dietary supplements nearly six months after the deadline for compliance with the GMP final rule.