Tag Archives: HARPC

FDA Issues First Warning Letter for Alleged HARPC Violations

On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice (CGMPs) provisions at 21 CFR Part 117. While FDA has cited violations of the revised CGMP regulations in prior Warning Letters, this appears to be … Continue Reading

FDA’s ‘Data Dashboard’ Expansion Makes Supply-Chain Verification Searches Easier

  Three FDA Food Safety Modernization Act (FSMA) rules (Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals) require importers and facilities to … Continue Reading

FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations

As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. Small businesses may be eligible for certain exemptions and have later compliance dates than larger businesses covered … Continue Reading

FDA Issues Draft Guidance on HARPC for Animal Food

As previously reported on this blog, FDA published final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. The Federal Register publication of the final animal HARPC rule (80 Fed. Reg. 56170) can be found … Continue Reading

FDA Releases Sixth Chapter of Draft Guidance for the Human HARPC Rule

As our readership is well aware, the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. To facilitate compliance … Continue Reading

FDA Launches Food Safety Plan Builder to Facilitate FSMA Compliance

The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. The new HARPC requirements implemented by the … Continue Reading

FDA Delays Certain FSMA Compliance Dates and Issues Draft Guidance on Preventive Controls for Human Food

FDA issues HARPC Draft Guidance and delays compliance dates for several key FSMA provisions. FDA issued a final rule today that extends and clarifies the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA).  These changes are intended to address concerns about the practicality of compliance with certain … Continue Reading

FSMA Guidance: Qualified Facility Q&A

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 the FDA Food Safety Modernization Act (FSMA).  Under both the human food rule and the animal food rule, “qualified facilities” are subject to modified requirements.  … Continue Reading

A Time to Train

Training options available in anticipation of upcoming human HARPC compliance date. Under FDA’s hazard analysis and risk-based preventive control (HARPC) requirements  for human food and animal food, a food facility’s compliance strategy must be overseen by a “preventive controls qualified individual.”  Under both rules, a preventive controls qualified individual is defined as someone who has … Continue Reading

FSMA Final Rule Follow-Up

K&H publishes summaries of FSMA final HARPC rules for human food and animal food. As promised, Keller and Heckman LLP has prepared summaries of FDA’s final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA). Click here for our summary of … Continue Reading

FSMA: Final HARPC Rules Published

Federal Register publications available for final rules to implement FSMA HARPC provisions for human and animal food. On September 10, 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA). On September 17, 2015, the final rules were published in the Federal Register. … Continue Reading

Finally, FSMA

FDA issues long-awaited final rules to implement FSMA HARPC provisions for human and animal food. FDA has issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA).  The rules are scheduled for publication in the Federal Register on September 17, 2015, and the … Continue Reading
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