FSMA Compliance Services
Strengthen Your Food Safety System Through Preventive Controls, Documentation Review, and FDA Readiness Support
The Food Safety Modernization Act (FSMA) established a preventive approach to food safety by requiring applicable food facilities to identify potential hazards, implement appropriate controls, monitor activities, verify effectiveness, and maintain supporting records.
Food businesses must continuously maintain and improve their food safety systems as products, processes, suppliers, and operational conditions change.
At PCQIServices.com, we provide professional FSMA Compliance Services to help food manufacturers, processors, beverage companies, ingredient suppliers, co-packers, contract manufacturers, importers, and private label brands evaluate, strengthen, and maintain their food safety programs.
Our experienced food safety professionals work remotely with your team to assess current practices, identify improvement opportunities, support preventive controls implementation, and improve readiness for regulatory inspections and customer reviews.
What Are FSMA Compliance Services?
FSMA Compliance Services provide professional support to help organizations understand, implement, and maintain food safety systems aligned with FDA Preventive Controls requirements.
Our services support organizations with:
- • FSMA compliance assessments
- • Preventive controls review
- • Food Safety Plan evaluation
- • Hazard analysis support
- • Documentation improvement
- • Corrective action planning
- • FDA inspection readiness
A strong FSMA compliance program helps organizations:
- • Identify and control food safety hazards
- • Improve operational consistency
- • Strengthen documentation practices
- • Reduce compliance risks
- • Prepare for inspections and audits
Why Is FSMA Compliance Important?
FSMA Compliance Services provide professional support to help organizations understand, implement, and maintain food safety systems aligned with FDA Preventive Controls requirements.
Our services support organizations with:
- • FSMA compliance assessments
- • Preventive controls review
- • Food Safety Plan evaluation
- • Hazard analysis support
- • Documentation improvement
- • Corrective action planning
- • FDA inspection readiness
A strong FSMA compliance program helps organizations:
- • Identify and control food safety hazards
- • Improve operational consistency
- • Strengthen documentation practices
- • Reduce compliance risks
- • Prepare for inspections and audits
Scope of FSMA Compliance Services
FSMA Compliance Gap Assessment
A gap assessment evaluates current food safety practices against applicable FSMA expectations.
We review:
- • Food Safety Plans
- • Hazard analyses
- • Preventive controls
- • Monitoring procedures
- • Verification activities
- • Corrective action systems
- • Recordkeeping practices
Our assessments identify opportunities for improvement and provide recommendations for strengthening food safety systems.
Preventive Controls Compliance Support
Preventive controls are a key component of FSMA food safety systems.
We support evaluation and improvement of:
- • Process preventive controls
- • Sanitation preventive controls
- • Allergen controls
- • Supply-chain controls
- • Other risk-based controls
Our team helps organizations evaluate whether preventive controls are appropriate, documented, and effectively implemented.
Food Safety Plan Review and Improvement
Food Safety Plans must accurately reflect current operations and food safety risks.
We assist with:
- • Food Safety Plan reviews
- • Hazard analysis updates
- • Preventive control evaluations
- • Procedure improvements
- • Recordkeeping improvements
Hazard Analysis Support
A complete hazard analysis is essential for identifying food safety risks.
We support evaluation of:
Biological Hazards
Including:
- • Pathogens
- • Microbial growth
- • Contamination risks
Chemical Hazards
Including:
- • Allergens
- • Chemical contamination
- • Naturally occurring hazards
Physical Hazards
Including:
- • Foreign materials
- • Equipment-related risks
Process and Ingredient Risks
Including:
- • Process conditions
- • Supplier risks
- • Ingredient hazards
FDA Inspection Readiness Support
FDA inspections require organizations to demonstrate effective implementation of their food safety systems.
We assist organizations with:
- • Documentation review
- • Record organization
- • Food Safety Plan review
- • Inspection preparation
- • Corrective action support
Our goal is to help organizations approach FDA inspections with organized documentation and confidence.
FSMA Documentation Improvement
Effective documentation demonstrates that food safety activities are implemented consistently.
We support review and improvement of:
- • Food Safety Plans
- • Procedures
- • Monitoring records
- • Verification records
- • Corrective action documentation
- • Training records
Corrective Action and Compliance Improvement Support
When gaps or findings are identified, organizations need effective corrective actions.
We support:
- • Gap evaluation
- • Root cause analysis
- • Corrective action planning
- • Preventive action recommendations
- • Effectiveness review
FSMA Preventive Controls Maintenance Support
Food safety systems must evolve as organizations change.
We support ongoing activities related to:
- • New products
- • New ingredients
- • Process changes
- • Supplier changes
- • Equipment modifications
- • Food safety program updates
Deliverables
Your FSMA Compliance engagement may include:
Compliance Assessment Deliverables
- • FSMA Gap Assessment
- • Food Safety System Review
- • Preventive Control Evaluation
- • Improvement Recommendations
Documentation Support
- • Food Safety Plan Review
- • Hazard Analysis Review
- • Procedure Recommendations
- • Recordkeeping Improvements
Implementation Support
- • Compliance Action Plan
- • Corrective Action Recommendations
- • FSMA Improvement Roadmap
- • Progress Review Support
Industries We Support
Our FSMA Compliance Services support:
- • Food Manufacturers
- • Beverage Manufacturers
- • Bakeries
- • Dairy Facilities
- • Seafood Processors
- • Produce Operations
- • Frozen Food Manufacturers
- • Ingredient Manufacturers
- • Snack Food Companies
- • Dietary Supplement Manufacturers
- • Contract Manufacturers
- • Co-Packers
- • Importers
- • Private Label Brands
- • Food Distributors
Why Choose PCQIServices.com?
FSMA compliance requires more than having documents. Organizations need practical systems that are implemented, maintained, and continuously improved.
Companies choose PCQIServices.com because we provide:
- • FSMA Preventive Controls expertise
- • Food Safety Plan support
- • Hazard analysis guidance
- • Compliance gap assessments
- • Documentation improvement
- • FDA readiness support
- • Practical implementation recommendations
- • Remote nationwide and international service
Our objective is to help organizations establish stronger preventive food safety systems and maintain ongoing compliance confidence.
Frequently Asked Questions
What is FSMA?
The Food Safety Modernization Act (FSMA) is a U.S. food safety law designed to shift food safety practices from responding to contamination events toward preventing them through proactive risk-based controls.
Who needs FSMA compliance support?
FSMA compliance support is beneficial for food facilities that manufacture, process, pack, or hold food products and need assistance maintaining preventive food safety systems.
Is FSMA compliance only about documentation?
No. FSMA compliance involves implementing effective food safety systems, including hazard analysis, preventive controls, monitoring, verification, corrective actions, and recordkeeping.
Can FSMA compliance services be performed remotely?
Yes. Many FSMA support activities, including document review, gap assessments, system evaluations, and improvement planning, can be performed remotely.
How often should FSMA programs be reviewed?
FSMA programs should be reviewed and updated as operations change, new risks are identified, or improvements are needed to maintain effective food safety controls.
FDA FSMA Preventive Controls Regulation – 21 CFR Part 117
The FDA Food Safety Modernization Act (FSMA) Preventive Controls regulation establishes requirements for applicable human food facilities to perform hazard analysis, implement risk-based preventive controls, conduct monitoring and verification activities, establish corrective actions, and maintain records.
Under 21 CFR Part 117, covered facilities are expected to maintain food safety systems that are appropriate for their products, processes, and identified hazards.
PCQIServices.com provides FSMA Compliance Services to help organizations evaluate, strengthen, and maintain food safety systems aligned with FDA expectations.
Request a Free Consultation
Need assistance strengthening your FSMA compliance program?
Partner with PCQIServices.com for professional FSMA Compliance Services designed to help organizations improve preventive controls, strengthen documentation, and maintain effective food safety systems.
- ✔ FSMA Gap Assessments
- ✔ Preventive Controls Support
- ✔ Food Safety Plan Review
- ✔ FDA Readiness Assistance
- ✔ Remote Nationwide & International Service
Contact us today to discuss your FSMA compliance requirements and food safety objectives.
Fees and Subscriptions
Pricing Structure:
| Service Tier | One-Time Setup Fee | Monthly Maintenance Fee | Included Categories |
|---|---|---|---|
| Standard | $1,900 | $950/month | 1 food safety plan (single category) |
| Enhanced | $3,200 | $1,900/month | Up to 2 food safety plans (e.g., bakery + dairy) |
| Premium | $4,800 | $2,750/month | Up to 4 food safety plans + mock audit, annual review |
| Enterprise | Custom Quote | Custom Quote | 5+ food categories or multiple facilities/brands |
Volume discounts available for multi-site clients or corporate accounts.
Need Expert PCQI Support?
Partner with our experienced Preventive Controls Qualified Individuals (PCQIs) for practical FDA compliance guidance, documentation support, Food Safety Plan development, regulatory consulting, and ongoing compliance services tailored to your operation.
