The Food Safety Modernization Act (FSMA) has shifted the U.S. Food and Drug Administration’s (FDA) focus to preventing foodborne illness, to ensure animal food is safe for consumption. 21 CFR Part 507 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 animal food. The FDA carefully monitors facilities that manufacture, process, pack or hold animal food to ensure safety. The mandated and required regulations include implementing good manufacturing practice (GMP) regulations, a food safety plan, analyzing hazards, establishing a recall plan and implementing risk-based preventive controls.
Contact us today to learn more about our 21 CFR Part 507 consulting services and how we can assist your organization with 21 CFR Part 507 compliance.
Benefits of 21 CFR Part 507
• Ensure the safety of animal food
• Comply with federal and statutory laws and regulations
• Prevent animal food contamination
• Reduce risks to animal food
• Meet requirements for FDA FSMA compliance
How We Can Help
The ISO 9001 Group understands 21 CFR Part 507 regulations and how to comply with them. Our FDA 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 FSMA regulations to ensure effective, efficient and compliant good manufacturing practices.
Our proven, hands-on consulting service ensures that your food manufacturing practices comply with FDA regulations and pass FDA inspections.
21 CFR Part 507 Overview
Subpart A – General provisions
Subpart B – Current Good Manufacturing Practice
• Plant and grounds
• Water supply and plumbing, 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 – 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 E – 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.
Subpart F – Requirements Applying to Records That Must Be Established and Maintained
• Natural or unavoidable defects in food for human use that present no health hazard
Subpart G – Defect Action Levels
• 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.
Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.