FDA has issued two draft guidance documents to assist industry with the implementation of Preventive Controls and Current Good Manufacturing Practices under the Animal Food Rule and another draft guidance
Continue Reading FDA Issues Additional FSMA Draft Guidance Documents for Animal Foods and the Classification of Activities for Farms and Facilities
FSMA Final Rule: Food Facility Registration
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FDA amends food facility registration requirements.
- Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or
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FDA Guidance: Prior Notice
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FDA issues third edition of guidance regarding prior notice for imported food.
- Under Section 801(m) of the Federal Food, Drug, and Cosmetic Act, FDA requires the submission of “prior notice”
FSMA Final Rule Follow-Up
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K&H publishes summary of FSMA final rule to implement intentional adulteration requirements for human food.
- As promised, Keller and Heckman LLP has prepared a summary of FDA’s final rule
FSMA Final Rule Watch: Intentional Adulteration
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FDA releases final rule to implement FSMA intentional adulteration provisions for human food.
- On May 26, 2016, FDA released its final rule to implement the intentional adulteration (or “food
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FSMA Guidance: Qualified Facility Q&A
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FDA issues draft guidance regarding “qualified facilities” under FSMA HARPC framework.
- In September 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions of
FSMA Flash: Upcoming Public Meetings
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FDA hosting three public meetings to focus on FSMA import provisions.
- With FSMA implementation in full swing, FDA has announced that it will be hosting three one-day public meetings in
Oh, Canada (An FSVP Update)
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FDA recognizes Canada’s food safety system as comparable to U.S.
- As previously covered on this blog, FDA has issued a final rule to implement its Foreign Supplier Verification Program
FSMA Final Rule Watch: Whistleblower Protection
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OSHA issues final rule implementing FSMA whistleblower provisions.
- The FDA Food Safety Modernization Act (FSMA) added section 1012 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide
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FSMA Final Rule Follow-Up
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K&H publishes summary of FSMA final rule to implement sanitary transportation requirements for human and animal food.
- As promised, Keller and Heckman LLP has prepared a summary of FDA’s