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The Food Safety Modernization Act (FSMA) has shifted the U.S. Food and Drug Administration’s (FDA) focus to preventing foodborne illness, to ensure food is safe for human consumption. 21 CFR Part 117 is one of seven major FDA rules to implement FSMA, which include specific actions that must be taken at each point in the global supply chain to prevent contamination to human food. The FDA carefully monitors food facilities that manufacture, process, pack, or hold human food to ensure consumer safety. The mandated and required regulations include implementing good manufacturing practice (GMP) regulations, hazard analysis and risk-based preventive controls, a food safety plan and a risk-based supply-chain program.


Contact us today to learn more about our 21 CFR Part 117 consulting services and how we can assist your organization with 21 CFR Part 117 compliance.

Benefits of 21 CFR Part 117

• Ensure consumer safety

• Comply with federal and statutory laws and regulations

• Prevent food safety hazards

• Reduce risk of foodborne illness 

• Meet requirements for FDA FSMA compliance



How We Can Help

The ISO 9001 Group understands 21 CFR Part 117 regulations how to comply with them. Our consulting service provides assistance with FDA registration, pre-audit, FDA inspections and responding to FDA warnings letters. Our consultants will work with you to implement the applicable FDA regulations to ensure effective, efficient and compliant good manufacturing practices.


Federal Regulations:

21 CFR Part 117. Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Human Food


Our proven, hands-on consulting service ensures that your food manufacturing practices comply with FDA regulations and pass FDA inspections.



21 CFR Part 117 Overview

Subpart A – General provisions

Subpart B – Current Good Manufacturing Practice

• Personnel

• Plant and grounds

• Sanitary operations

• Sanitary facilities and controls, etc.

Subpart C – Hazard Analysis and Risk-Based Preventive Controls

• Food safety plan

• Hazard analysis

• Preventive controls

• Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control, etc.

Subpart D – Modified Requirements

• Modified requirements that apply to a qualified facility

• Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food

Subpart E – Withdrawal of a Qualified Facility Exemption

• Circumstances that may lead FDA to withdraw a qualified facility exemption

• Issuance of an order to withdraw a qualified facility exemption

• Contents of an order to withdraw a qualified facility exemption

• Compliance with, or appeal of, an order to withdraw a qualified facility exemption, etc.

Subpart F – Requirements Applying to Records That Must Be Established and Maintained

• Records subject to the requirements of this subpart

• General requirements applying to records

• Additional requirements applying to the food safety plan

• Requirements for record retention, etc.

Subpart G – Supply-Chain Program

• Requirement to establish and implement a supply-chain program

• General requirements applicable to a supply-chain program

• Responsibilities of the receiving facility

• Using approved suppliers, etc.


Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.

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