- On August 9, 2024, FDA issued a warning letter to Austrofoods S.A.S., the Peruvian-based manufacturer that produced lead-contaminated apple cinnamon fruit puree pouches that were the subject of a recall
FDA Revises Draft HARPC Guidance
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- Yesterday FDA announced the release of revisions to the introduction and Appendix I of its “Hazards Analysis and Risk-Based Preventive Controls for Human Food” (HARPC) Draft Guidance. The guidance
FDA Publishes Two New Chapters of Human Foods HARPC Draft Guidance
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- On September 26, FDA announced the availability of two new chapters of the Draft Guidance for Industry: Hazard Analysis and Rick-Based Preventive Controls for Human Food. The two new
“On the Go” Ice Cream Cups Recalled Due to Listeria Contamination
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- On August 9, Real Kosher Ice Cream voluntarily recalled soft serve on the go ice cream and sorbet cups due to potential contamination with Listeria monocytogenes, an organism which
Consent Decree Entered for Real Water Hepatitis Outbreak
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- On June 1, the FDA published a press release announcing that Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they can comply with the Federal
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FDA Issues Two Warning Letters for Undeclared Allergens
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- On May 4, the FDA published two Warning Letters for undeclared allergens and the “introduction or delivery for introduction into interstate commerce of any food that is misbranded” which is
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Comments on Chapter 14: Recall Plan of FDA’s Draft Guidance on Human HARPC Rule Due February 4
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- As previously reported on this blog, the Food and Drug Administration (FDA) has been issuing guidance chapters on compliance with its Final Rule for Preventive Controls for Human Food on
FDA Releases Chapter 14: Recall Plans in the Latest Installment to the Agency’s Multi-Chapter Draft Guidance on the Human HARPC Rule
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- As discussed here, the Food and Drug Administration (FDA) has been rolling out chapters, as they are completed, to provide guidance on complying with FDA’s Final Rule for Preventive
FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food
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- The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by
FDA Issues Draft Guidance on Produce Safety Requirements under FSMA
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- FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA).
- The FSMA final rule on
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