AG/FDA Blog

FSMA Update: FDA Releases Guidance Documents on CGMP Requirements of Animal Food Rule and Exemptions from FSMA Requirements of Human and Animal Food Rules

On October 19, 2017, FDA announced the publication of two guidance documents to assist industry stakeholders in compliance with regulations promulgated pursuant to the Food Safety Modernization Act (FSMA): #235 – Current Good Manufacturing Practic… Read More
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Regulatory Round-Up Newsletter, Winter 2016

On behalf of the Agriculture practice group at OFW Law, following is a copy of our Winter 2016 newsletter.  We hope you find it useful.  To receive this periodic newsletter by e-mail, please contact Carrie Morgan. Read More
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It's Not What You Call It - It's How You Manage It

By OFW Law and HACCP Consulting Group Under the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) made the decision that registered facilities would be required to implement food safety plans based on preventive controls… Read More
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FDA Final Rule: CGMPs and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

On September 17, 2015, the federal Food and Drug Administration (“FDA”) released a major final rule to implement the Food Safety Modernization Act (“FSMA”): Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Contr… Read More
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Doom and Gloom Certified as Lead Instructors for FSCPA Preventive Controls for Human Food

Happy Holidays from OFW Law’s Dr. Barbara Masters, D.V.M., and Jolyda Swaim, A.K.A Dr. Doom and Ms. Gloom.  As 2016 approaches, it is time for many of you to start considering the need to comply with the mandatory training requirements for… Read More
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Dr. Doom: Do You Take Time to Review Records?

Yes, it is recognized that as part of Hazard Analysis Critical Control Point (HACCP) verification, a responsible plant person is “reviewing records generated” as part of the HACCP program.  In addition, the plant has someone that conducts pre-sh… Read More
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Doom and Gloom Challenges for Success Under FSMA

Are you set up to succeed under the Food and Drug Administration’s (FDA) preventive controls final rules for human and animal food that have been sent to the Federal Register?  Have you taken preliminary steps in your operation in advance of these… Read More
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FDA Updates 4 Proposed Rules Implementing FSMA

The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA Food Safety Modernization Act (FSMA).  The proposed revisions address: Current Good Manufacturing Practice and Haz… Read More
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Fishy Fishy – MOU between FSIS and FDA to Improve Interagency Cooperation

There have been on-going questions regarding the regulatory oversight of catfish inspection.  To address this concern, the 2014 Farm Bill required the Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) to create a M… Read More
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Tune up and Be Ready - A Practice Tip from Dr. Doom

FSIS has indicated that based on some recent “negative events;” they will be increasing verification activities.  Increased verification should not mean increased noncompliance.  We should do what we say we are going to do and document… Read More
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