Tag Archives: GMP

FDA Launches Dashboard to Track FSMA Progress

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On September 30, 2019, FDA announced the establishment of the Food Safety Dashboard, which is designed to measure the progress of the seven foundational rules of the Food Safety Modernization Act (FSMA), to track their impact, and to help FDA to refine its implementation of the rules. As FDA embarks on a New Era of Smarter … Continue Reading

FDA Warns Bakery to Fix cGMP Violations and Remove the “Love”

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On September 22, 2017, following an inspection of the company’s manufacturing facility, the U.S. Food and Drug Administration (FDA) issued a warning letter to Nashoba Brook Bakery regarding significant current Good Manufacturing Practice (cGMP) violations.  cGMPs describe the methods, equipment, facilities, and controls for producing food.  cGMPs prescribe the minimum sanitary and processing requirements for … Continue Reading

Ingredient GMPs Revisited

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Organic & Natural Health Association files Citizen Petition to request application of dietary supplement GMPs to ingredient suppliers. As previously covered on this blog, the Organic & Natural Health Association (ONHA) has indicated its interest in seeing FDA extend the application of current Good Manufacturing Practice (GMP) regulations in 21 CFR Part 111 (which apply to finished dietary … Continue Reading

Ingredient GMPs?

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Trade association proposes application of dietary supplement GMPs to raw material suppliers. FDA’s current Good Manufacturing Practice (GMP) regulations in 21 CFR Part 111 apply to finished dietary supplements, but not directly to the raw materials or dietary ingredients used in their production. In yet another development related to the New York Attorney General’s (AG) investigation into … Continue Reading
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