FDA, FSMA, & USDA Food Safety Compliance Support 

SCS Consulting Services food safety experts assist companies with FDA (21 CFR), FSMA Preventive Controls, FSVP, USDA, FSIS, HACCP, customer and retailer, label and packaging, GMPs, supplier programs, and documentation for both domestic and imported foods.

Our food safety consultants provide the following FSMA support:

• Hazard analysis and preventive control identification  
• Validation/Verification planning and records  
• Monitoring procedures and corrective actions  
• Recordkeeping system design  
• Environmental monitoring program guidance  
• PCQI level support and training  

FSMA 204, also known as the FDA Food Traceability Rule, requires companies handling certain high-risk foods to maintain enhanced traceability records. The rule is designed to improve food safety by helping the FDA quickly identify and remove potentially contaminated products from the supply chain.

FSMA 204 applies to businesses that manufacture, process, pack, or hold foods on the FDA's Food Traceability List (FTL). This includes many growers, manufacturers, processors, distributors, warehouses, and importers handling covered foods intended for the U.S. market. 

The FDA's current compliance and enforcement date for the Food Traceability Rule is July 20, 2028. Organizations should begin preparing well in advance, as implementation often requires changes to processes, records, and supply chain data management. 

Covered companies must maintain specific Key Data Elements (KDEs) at designated Critical Tracking Events (CTEs) throughout the supply chain. Businesses must also be able to provide traceability records to the FDA within 24 hours when requested. 

SCS Consulting Services helps organizations assess applicability, identify traceability gaps, develop traceability plans, evaluate current recordkeeping processes, train personnel, and implement practical compliance solutions that align with FDA requirements. Our goal is to help you achieve compliance without unnecessary operational complexity.

Not necessarily. While some organizations may benefit from new technology solutions, FDA compliance is based on the ability to capture, maintain, and retrieve required traceability information. Many companies can leverage existing systems with process improvements and targeted enhancements. 

Implementation timelines vary based on your products, supply chain complexity, and current traceability capabilities. Many organizations begin with a gap assessment to identify requirements, prioritize improvements, and establish a roadmap for compliance before the enforcement deadline.

Our food safety consulting experts can create, validate, update, and verify HACCP plans for meat, poultry, and egg products, plus prerequisite programs, supplier compliance, micro testing programs, label submissions, and NR responses.  

Yes. SCS Consulting Servies provides response strategies for 483s, Warning Letters, NRs, and NOIEs; with root cause analysis; corrective action documentation; and long-term system improvements. 

The SCS Consulting Services food safety team provides:

• Food Safety / HACCP plan reassessments  
• Documentation reviews and record checks  
• Training program evaluation  
• Facility walkthroughs and GMP verification  
• Internal audits and readiness assessments  

Yes. SCS Consulting Services provides training on the following regulatory programs: PCQI, HACCP, Food Defense IAVA, GMPs, allergen management, sanitation, crisis management, internal auditing, FSVP, and GFSI courses. 

Yes. The SCS Consulting Food Safety team can help you develop a new regulatory program or revise your existing one. We specialize in FSMA Food Safety Preventive Control Plans, HACCP plans, SOPs, EMP, recall programs, allergen controls, and more tailored to your operations. 

Yes. We standardize documentation, build enterprise controls, train site champions, and implement consistent verification across sites. 

Usually within 1–2 weeks; urgent issues (FDA/USDA warning letters, Recalls, Outbreaks) can be supported within 24 hours.

Yes. SCS Consulting Services offers monthly, quarterly, or annual programs including internal audits, regulatory updates, horizon scanning, supplier reviews, and coaching. 

Pricing for FDA, FSMA, and USDA support varies based on the scope of regulatory needs, the complexity of your facility or products, and the level of documentation, assessment, or inspection support required. We tailor each engagement according to your operational processes, compliance objectives, and the depth of technical expertise needed to ensure your organization remains aligned with regulatory expectations. Request a personalized quote today.