A HACCP plan is a written, science-based food safety program that identifies biological, chemical, and physical hazards in a food process and establishes controls at Critical Control Points (CCPs) to prevent, eliminate, or reduce those hazards to safe levels. FDA Registration Assistance develops fully documented HACCP plans that meet all FDA guidelines and inspection requirements.

HACCP plans are required by FDA for seafood processors (21 CFR Part 123), juice processors (21 CFR Part 120), and are strongly mandated under FSMA's Preventive Controls rules for human and animal food. FDA Registration Assistance helps all food facility types — domestic and foreign — develop compliant HACCP plans tailored to their specific product and process.

The seven HACCP principles are: (1) Conduct a Hazard Analysis, (2) Identify Critical Control Points, (3) Establish Critical Limits, (4) Establish Monitoring Procedures, (5) Establish Corrective Actions, (6) Establish Verification Procedures, and (7) Establish Recordkeeping Systems. FDA Registration Assistance ensures all seven principles are fully documented and defensible during an FDA inspection.

Prerequisite programs are foundational food safety practices — including cGMPs, sanitation controls, pest management, allergen programs, and supplier controls — that must be in place before a HACCP plan can function effectively. FDA Registration Assistance reviews your prerequisite programs as part of every HACCP plan development engagement to ensure a solid compliance foundation.

FDA Registration Assistance supports HACCP plan development and review for all food categories — including seafood, juice, dairy, meat & poultry, ready-to-eat foods, dietary supplements, infant formula, animal food, and any other FDA-regulated food or beverage product manufactured domestically or imported into the U.S.

Yes. FDA Registration Assistance reviews existing HACCP plans to identify gaps, verify that all seven principles are properly addressed, confirm that CCPs and critical limits are scientifically valid, and ensure recordkeeping and corrective action procedures meet FDA expectations. A plan review is recommended before any FDA inspection or audit.

Turnaround time depends on product complexity, the number of process steps, and existing documentation. FDA Registration Assistance typically delivers a complete HACCP plan within 7–14 business days. Plan reviews and gap assessments are often completed faster. Contact FDA Registration Assistance to discuss your specific timeline.

A HACCP plan must be reviewed and updated whenever there are changes to ingredients, equipment, processes, packaging, or distribution methods. FDA Registration Assistance recommends an annual review as a best practice and provides ongoing support to ensure your plan always reflects your current operations and remains FDA inspection-ready.

Yes, for certain categories. Seafood and juice imports must comply with HACCP regulations under 21 CFR Parts 123 and 120 respectively. Additionally, under FSMA's Preventive Controls rules, foreign food facilities must apply preventive controls that align with HACCP principles. FDA Registration Assistance ensures imported food products meet all applicable FDA food safety requirements.

HACCP is a systematic hazard-based food safety approach originally developed for specific categories (seafood, juice). FSMA's Preventive Controls rule (21 CFR Part 117) broadened these requirements to all registered human food facilities and is built on HACCP principles. FDA Registration Assistance is experienced in both frameworks and ensures your food safety plan meets whichever standard applies to your facility.

Yes. Foreign food facilities exporting to the U.S. must comply with FDA food safety requirements, including HACCP where applicable. Under FSMA, foreign facilities must also meet Preventive Controls standards. FDA Registration Assistance works with food manufacturers in over 135 countries to develop HACCP plans and ensure full FDA compliance for U.S. market entry.

Yes. FDA Registration Assistance reviews all supporting prerequisite programs — including cGMPs, sanitation standard operating procedures (SSOPs), pest control, allergen management, and supplier verification programs — to confirm they adequately support your HACCP plan and meet FDA regulatory expectations.

During an FDA inspection, investigators review your HACCP plan documentation, monitoring records, corrective action logs, and verification activities. They assess whether CCPs are properly identified, critical limits are validated, and recordkeeping is complete. FDA Registration Assistance prepares your facility for inspection by ensuring all HACCP documentation is complete, current, and defensible.

Yes. Any change in ingredients, processing steps, equipment, or packaging requires a HACCP plan review and possible update. FDA Registration Assistance provides ongoing HACCP maintenance services to ensure your plan always reflects your current operations and remains fully compliant with FDA requirements whenever your business evolves.

A HACCP plan is a critical component of FDA food safety compliance, but it must be supported by active prerequisite programs, proper recordkeeping, staff training, and ongoing verification activities. FDA Registration Assistance provides a complete food safety compliance review — ensuring your HACCP plan is not only written correctly but fully implemented and operational.

FDA Registration Assistance charges $1,500 USD for the first product and $850 USD for each additional product. Pricing may vary based on process complexity and the number of CCPs involved. Contact FDA Registration Assistance to discuss your specific HACCP needs and receive a tailored quote.